1,019 Regulatory Affairs Positions jobs in India
Regulatory Affairs Manager
Bangalore, Karnataka
ThermoFisher Scientific
Posted 16 days ago
Job Viewed
Job Description
**Work Schedule**
Other
**Environmental Conditions**
Office
**Job Description**
**Responsibilities:**
The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.
+ Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met.
+ Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP.
+ Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements.
+ Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams.
+ Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications.
+ Lead local performance evaluations, tests, and clinical studies to support product registration in India.
+ Participate in Animal Health regulatory submissions and support the distributed team as needed.
+ Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions.
+ Review advertisement materials for compliance with MD/IVD regulations in South Asia.
+ Analyze new and existing regulations, preparing impact assessments for LSG projects.
+ Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
+ Participate in regulatory/quality audits, exhibitions, and conferences.
+ Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO.
+ Perform other tasks as assigned by the line manager.
**Minimum Requirements:**
Education and Qualifications:
+ Bachelor's degree or higher in Engineering, Sciences, or Medicine.
+ Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations.
**Essential Skills and Abilities:**
+ Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations.
+ Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
+ Strong planning and organizational skills for regulatory submissions and project management.
+ Excellent communication skills, including written, verbal, and presentation abilities.
+ Strong project management skills with the ability to lead regulatory projects.
+ Strong analytical skills, proactive, and a resourceful problem solver.
+ Ability to work effectively under pressure and manage flexible working hours.
+ Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments.
+ Experience in leading compliance activities, including post-market surveillance and advertisement review.
+ Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies.
+ Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Other
**Environmental Conditions**
Office
**Job Description**
**Responsibilities:**
The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.
+ Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met.
+ Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP.
+ Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements.
+ Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams.
+ Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications.
+ Lead local performance evaluations, tests, and clinical studies to support product registration in India.
+ Participate in Animal Health regulatory submissions and support the distributed team as needed.
+ Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions.
+ Review advertisement materials for compliance with MD/IVD regulations in South Asia.
+ Analyze new and existing regulations, preparing impact assessments for LSG projects.
+ Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
+ Participate in regulatory/quality audits, exhibitions, and conferences.
+ Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO.
+ Perform other tasks as assigned by the line manager.
**Minimum Requirements:**
Education and Qualifications:
+ Bachelor's degree or higher in Engineering, Sciences, or Medicine.
+ Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations.
**Essential Skills and Abilities:**
+ Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations.
+ Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
+ Strong planning and organizational skills for regulatory submissions and project management.
+ Excellent communication skills, including written, verbal, and presentation abilities.
+ Strong project management skills with the ability to lead regulatory projects.
+ Strong analytical skills, proactive, and a resourceful problem solver.
+ Ability to work effectively under pressure and manage flexible working hours.
+ Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments.
+ Experience in leading compliance activities, including post-market surveillance and advertisement review.
+ Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies.
+ Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Manager
Hyderabad, Andhra Pradesh
Amgen
Posted 16 days ago
Job Viewed
Job Description
**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Job Summary:**
Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.
Join us in revolutionizing regulatory submissions through cutting-edge data automation!
**Key Responsibilities:**
+ Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
+ Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
+ Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
+ Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
+ Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
+ Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
+ Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
+ Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of directly related experience OR
+ Bachelor's degree and 5 years of directly related experience
+ Experience managing and leading a team in a regulatory or compliance environment
**Preferred Qualifications:**
+ Degree in life sciences, digital or data science, biochemistry, or chemistry
+ Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements
+ Background or basic experience in digitalization, automation, software development
+ Background in manufacturing, process development, quality control, or quality assurance
+ Hands-on experience with Veeva Vault platforms and regulatory technology solutions.
**What we expect from you**
We are all different, yet we all use our unique contributions to serve patients.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination** Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Job Summary:**
Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.
Join us in revolutionizing regulatory submissions through cutting-edge data automation!
**Key Responsibilities:**
+ Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
+ Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
+ Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
+ Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
+ Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
+ Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
+ Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
+ Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of directly related experience OR
+ Bachelor's degree and 5 years of directly related experience
+ Experience managing and leading a team in a regulatory or compliance environment
**Preferred Qualifications:**
+ Degree in life sciences, digital or data science, biochemistry, or chemistry
+ Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements
+ Background or basic experience in digitalization, automation, software development
+ Background in manufacturing, process development, quality control, or quality assurance
+ Hands-on experience with Veeva Vault platforms and regulatory technology solutions.
**What we expect from you**
We are all different, yet we all use our unique contributions to serve patients.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination** Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Affairs Manager
New Delhi, Delhi
Self-employed
Posted 1 day ago
Job Viewed
Job Description
Company Description
Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from Gastrointestinal to Neurology
Role Description
This is a full-time on-site role for a Regulatory Affairs Manager located in New Delhi. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documentation, and managing quality systems. Additional tasks will include coordinating with internal teams to align business strategies with regulatory requirements, and staying updated with new regulations and guidelines.
Qualifications
- Skills in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
- Experience with Regulatory Submissions
- Proficiency in managing Quality Systems
- Strong organizational and time-management skills
- Excellent written and verbal communication skills
- Ability to work independently and meet deadlines
- Experience in the healthcare or pharmaceutical industry is a plus
- Bachelor's degree in a relevant field such as Regulatory Affairs, Life Sciences, or Pharmacy
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Affairs Manager
Daman, Daman and Diu
BioTalent Search®
Posted 11 days ago
Job Viewed
Job Description
Our client is a leading global organization in Women’s Health with a strong focus on contraceptive and reproductive healthcare solutions. With state-of-the-art manufacturing facilities and in-house R&D expertise, the company has developed innovative medical devices and solutions that have empowered millions of women worldwide. The organization is certified under ISO 9001, ISO 14001, WHO GMP, CE, and ISO 13485 standards.
Job Description – Manager, Regulatory Affairs (RA)
Location: Daman
Experience: 12+ Years (relevant regulatory affairs experience)
Qualification: M.Pharm
Key Responsibilities
- Develop and implement global regulatory strategies to ensure timely product approvals and market access across multiple health authorities (FDA, EMA, MHRA, TGA, Health Canada, etc.).
- Provide regulatory intelligence and strategic advice to senior management on evolving regulations and their potential impact on business.
- Collaborate with R&D, Quality, Manufacturing, and Marketing teams to align regulatory activities with overall business goals.
- Prepare, compile, and submit Controlled Correspondence, Pre-submission Meeting Requests, and Scientific Advice for US, EU, Canada, and other global markets.
- Evaluate pre-PIFs and provide regulatory submission requirements for US & EU, with extended submissions for Australia, Canada, and other regions.
- Define and implement regulatory strategies to ensure business continuity and Day 1 launches in Europe, Canada, Australia, UK, China, and other key markets (Type IA/IB/II Supplements, Category 3 Notifications).
- Act as a CMC expert for initial submissions and lifecycle management in global markets (US, EU, Canada, Australia, China, and emerging regions) across multiple dosage forms: OSDs, Ophthalmics, Complex Injectables, and Liposomal products .
- Author and review CMC documentation (dossiers, technical files, deficiency responses), ensuring technical accuracy and compliance with agreed regulatory strategies.
- Lead cross-functional teams for new product development, regulatory submissions, and post-approval lifecycle management.
- Ensure ongoing compliance with international regulatory standards ; manage audits and inspections by global authorities.
- Manage and mentor the Regulatory Affairs team , ensuring compliance with applicable guidelines for pharmaceuticals and biologics (ANDA, NDA, DCP, CP, ANDS applications).
- Conduct regulatory evaluations of change controls, deviations, OOS/OOT events, and other quality incidents to assess regulatory impact.
- Utilize and oversee regulatory software systems such as LIMS, TrackWise, PharmaReady, Amplexor , etc.
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Manager
Mumbai, Maharashtra
Wellbeing Nutrition
Posted today
Job Viewed
Job Description
Key Roles and Responsibilities:
Regulatory Compliance & Licensing:
- Lead and manage all regulatory approvals, licensing, and registration activities across relevant regulatory authorities to ensure timely approvals (FSSAI, Tea Board of India, MSME, Factory License, Trade License, etc.).
- Develop and oversee robust systems for regulatory compliance reporting (e.g., Whistleblower avenues).
- Establish and implement compliance frameworks aligned with food safety and regulatory guidelines.
- Provide proactive strategic advice on regulatory matters across domains including Health, Safety, Environment, Food Safety, Pollution Control, Customs, and Product Liability.
- Ensure up-to-date renewals and compliance for all essential business licenses across group companies and associates.
- Ensure full compliance with FSSAI and Legal Metrology standards across all products and packaging.
- Continuously monitor, interpret, and implement changes to food regulations (especially FSSAI updates).
Stakeholder Management & Coordination:
- Establish and manage an effective stakeholder engagement matrix with central/state authorities.
- Liaise with regulatory bodies, consultants, and local agencies for licensing processes, issue resolution, and standard implementation.
- Maintain all necessary documentation and ensure readiness for regulatory review or inspections.
Quality Control & Food Safety:
- Coordinate with QC teams to ensure internal and external product testing complies with FSSR and other regulatory standards.
- Lead regulatory and food safety activities for India and international markets to ensure product compliance.
- Drive the resolution of product safety issues and customer complaints through testing, analysis, and action.
Product Labelling & Trademark Compliance:
- Validate and ensure accuracy of product labelling for compliance with Indian and international regulations (e.g., USFDA, EU).
- Collaborate with marketing and design teams for creation and approval of compliant labels and packaging artwork.
- Maintain and manage barcode databases and ensure labelling readiness for retail and export.
- Coordinate with external agencies for application, renewal, and protection of trademarks. Review legal drafts for oppositions/counter-statements and provide required documentation.
Regulatory Audits:
- Develop internal control systems and monitor adherence through regular and surprise audits at plant, warehouse, and store levels.
- Create and execute quarterly/half-yearly audit plans; lead both internal and external audit activities.
- Identify process gaps and risks, present findings to management, and drive corrective actions.
- Maintain weekly/monthly compliance trackers and provide updates to senior leadership.
- Collaborate with HODs and external auditors to ensure full statutory, regulatory, and client compliance.
Required Skills & Qualifications:
- Bachelor’s Degree in Nutrition, Food Science, or Nutraceuticals (Mandatory)
- Master’s Degree in Nutraceuticals (Preferred)
- In-depth knowledge of Nutraceutical NPD, regulatory affairs, FSSAI, Legal Metrology, and international food regulations.
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Manager
New Delhi, Delhi
Self-employed
Posted 2 days ago
Job Viewed
Job Description
Company Description
Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from Gastrointestinal to Neurology
Role Description
This is a full-time on-site role for a Regulatory Affairs Manager located in New Delhi. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documentation, and managing quality systems. Additional tasks will include coordinating with internal teams to align business strategies with regulatory requirements, and staying updated with new regulations and guidelines.
Qualifications
- Skills in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
- Experience with Regulatory Submissions
- Proficiency in managing Quality Systems
- Strong organizational and time-management skills
- Excellent written and verbal communication skills
- Ability to work independently and meet deadlines
- Experience in the healthcare or pharmaceutical industry is a plus
- Bachelor's degree in a relevant field such as Regulatory Affairs, Life Sciences, or Pharmacy
This advertiser has chosen not to accept applicants from your region.
5
Regulatory Affairs Manager
Bengaluru, Karnataka
Thermo Fisher Scientific
Posted today
Job Viewed
Job Description
: Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met. Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP. Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements. Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams. Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications. Lead local performance evaluations, tests, and clinical studies to support product registration in India. Participate in Animal Health regulatory submissions and support the distributed team as needed. Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions. Review advertisement materials for compliance with MD/IVD regulations in South Asia. Analyze new and existing regulations, preparing impact assessments for LSG projects. Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization. Participate in regulatory/quality audits, exhibitions, and conferences. Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO. Perform other tasks as assigned by the line manager. Bachelor’s degree or higher in Engineering, Sciences, or Medicine. Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations. Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations. Acute awareness of regulatory changes and skilled in regulatory and strategic analysis. Strong planning and organizational skills for regulatory submissions and project management. Excellent communication skills, including written, verbal, and presentation abilities. Strong project management skills with the ability to lead regulatory projects. Strong analytical skills, proactive, and a resourceful problem solver. Ability to work effectively under pressure and manage flexible working hours. Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments. Experience in leading compliance activities, including post-market surveillance and advertisement review. Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies. Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.
The is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.
Minimum Requirements:
Education and Qualifications:
Essential Skills and Abilities:
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Regulatory affairs positions Jobs in India !
6
Regulatory Affairs Manager
Diu, Daman and Diu
BioTalent Search®
Posted today
Job Viewed
Job Description
Our client is a leading global organization in Women’s Health with a strong focus on contraceptive and reproductive healthcare solutions. With state-of-the-art manufacturing facilities and in-house R&D expertise, the company has developed innovative medical devices and solutions that have empowered millions of women worldwide. The organization is certified under ISO 9001, ISO 14001, WHO GMP, CE, and ISO 13485 standards.
Job Description – Manager, Regulatory Affairs (RA)
Location: Daman
Experience: 12+ Years (relevant regulatory affairs experience)
Qualification: M.Pharm
Key Responsibilities
- Develop and implement global regulatory strategies to ensure timely product approvals and market access across multiple health authorities (FDA, EMA, MHRA, TGA, Health Canada, etc.).
- Provide regulatory intelligence and strategic advice to senior management on evolving regulations and their potential impact on business.
- Collaborate with R&D, Quality, Manufacturing, and Marketing teams to align regulatory activities with overall business goals.
- Prepare, compile, and submit Controlled Correspondence, Pre-submission Meeting Requests, and Scientific Advice for US, EU, Canada, and other global markets.
- Evaluate pre-PIFs and provide regulatory submission requirements for US & EU, with extended submissions for Australia, Canada, and other regions.
- Define and implement regulatory strategies to ensure business continuity and Day 1 launches in Europe, Canada, Australia, UK, China, and other key markets (Type IA/IB/II Supplements, Category 3 Notifications).
- Act as a CMC expert for initial submissions and lifecycle management in global markets (US, EU, Canada, Australia, China, and emerging regions) across multiple dosage forms: OSDs, Ophthalmics, Complex Injectables, and Liposomal products .
- Author and review CMC documentation (dossiers, technical files, deficiency responses), ensuring technical accuracy and compliance with agreed regulatory strategies.
- Lead cross-functional teams for new product development, regulatory submissions, and post-approval lifecycle management.
- Ensure ongoing compliance with international regulatory standards ; manage audits and inspections by global authorities.
- Manage and mentor the Regulatory Affairs team , ensuring compliance with applicable guidelines for pharmaceuticals and biologics (ANDA, NDA, DCP, CP, ANDS applications).
- Conduct regulatory evaluations of change controls, deviations, OOS/OOT events, and other quality incidents to assess regulatory impact.
- Utilize and oversee regulatory software systems such as LIMS, TrackWise, PharmaReady, Amplexor , etc.
This advertiser has chosen not to accept applicants from your region.
7