123 Pharmaceutical Regulatory jobs in India
Senior Pharmaceutical Regulatory Affairs Specialist
400601 Thane, Maharashtra
₹95000 Annually
WhatJobs
Posted 5 days ago
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Job Description
Our client is a rapidly expanding pharmaceutical company seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist. This is a fully remote role, enabling you to contribute to our global mission from anywhere in India. You will play a critical role in ensuring that our pharmaceutical products comply with all relevant national and international regulations, from early-stage development through to market approval and post-marketing surveillance. This position demands a thorough understanding of drug development processes, regulatory submission requirements, and a proactive approach to navigating the complex regulatory landscape.
Responsibilities:
Responsibilities:
- Develop and execute regulatory strategies for drug product submissions (e.g., IND, NDA, ANDA, MAA).
- Prepare, review, and submit regulatory documentation to health authorities worldwide.
- Liaise directly with regulatory agencies (e.g., FDA, EMA, CDSCO) to facilitate timely approvals and respond to queries.
- Monitor and interpret evolving regulatory guidelines and legislation, advising the company on compliance implications.
- Conduct regulatory intelligence activities to identify emerging trends and potential challenges.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Manage and maintain regulatory compliance databases and documentation.
- Provide regulatory input and support to cross-functional teams, including R&D, clinical operations, manufacturing, and quality assurance.
- Oversee the regulatory aspects of product lifecycle management, including post-approval changes and annual reports.
- Train and mentor junior regulatory affairs personnel.
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
- A minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
- Demonstrated success in preparing and managing regulatory submissions for various product types.
- Expertise in global regulatory requirements and guidelines.
- Strong understanding of drug development, manufacturing, and quality control processes.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Proficiency in regulatory information management systems.
- Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines in a remote setting.
- Strong problem-solving and critical thinking skills.
- Experience with biologics or biosimilars is a significant advantage.
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0
Senior Pharmaceutical Regulatory Affairs Specialist
452001 Indore, Madhya Pradesh
₹95000 Annually
WhatJobs
Posted 5 days ago
Job Viewed
Job Description
Our client is a rapidly expanding pharmaceutical company seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist. This is a fully remote role, enabling you to contribute to our global mission from anywhere in India. You will play a critical role in ensuring that our pharmaceutical products comply with all relevant national and international regulations, from early-stage development through to market approval and post-marketing surveillance. This position demands a thorough understanding of drug development processes, regulatory submission requirements, and a proactive approach to navigating the complex regulatory landscape.
Responsibilities:
Responsibilities:
- Develop and execute regulatory strategies for drug product submissions (e.g., IND, NDA, ANDA, MAA).
- Prepare, review, and submit regulatory documentation to health authorities worldwide.
- Liaise directly with regulatory agencies (e.g., FDA, EMA, CDSCO) to facilitate timely approvals and respond to queries.
- Monitor and interpret evolving regulatory guidelines and legislation, advising the company on compliance implications.
- Conduct regulatory intelligence activities to identify emerging trends and potential challenges.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Manage and maintain regulatory compliance databases and documentation.
- Provide regulatory input and support to cross-functional teams, including R&D, clinical operations, manufacturing, and quality assurance.
- Oversee the regulatory aspects of product lifecycle management, including post-approval changes and annual reports.
- Train and mentor junior regulatory affairs personnel.
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
- A minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
- Demonstrated success in preparing and managing regulatory submissions for various product types.
- Expertise in global regulatory requirements and guidelines.
- Strong understanding of drug development, manufacturing, and quality control processes.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Proficiency in regulatory information management systems.
- Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines in a remote setting.
- Strong problem-solving and critical thinking skills.
- Experience with biologics or biosimilars is a significant advantage.
This advertiser has chosen not to accept applicants from your region.
1
Senior Pharmaceutical Regulatory Affairs Specialist
110001 Indore, Madhya Pradesh
₹88000 Annually
WhatJobs
Posted 5 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a highly skilled and experienced Senior Pharmaceutical Regulatory Affairs Specialist to contribute to their innovative drug development pipeline. This role is crucial for ensuring that our client's products meet all regulatory requirements for approval and marketing in various global markets. You will be responsible for preparing, submitting, and maintaining regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other essential documentation. This involves interpreting complex regulatory guidelines, liaising with health authorities (e.g., FDA, EMA), and collaborating with internal teams such as R&D, clinical operations, and manufacturing. The ideal candidate will possess a strong understanding of pharmaceutical regulations, drug development processes, and quality systems. Exceptional attention to detail, strong analytical skills, and excellent communication are paramount. This position offers a challenging and rewarding opportunity to influence the regulatory pathway of life-saving and life-enhancing medicines.
Responsibilities:
Qualifications:
Responsibilities:
- Prepare, review, and submit regulatory filings (e.g., INDs, NDAs, MAAs) to global health authorities.
- Interpret and apply complex regulatory guidelines and requirements to ensure compliance.
- Serve as a key liaison between the company and regulatory agencies, managing communications and responses.
- Develop and implement regulatory strategies for product development and lifecycle management.
- Ensure all regulatory documentation is accurate, complete, and submitted in a timely manner.
- Collaborate with R&D, clinical, manufacturing, and quality assurance teams to gather necessary information for submissions.
- Provide regulatory guidance and support throughout the drug development process.
- Maintain and update regulatory submission dossiers and databases.
- Monitor changes in the regulatory landscape and assess their impact on company products and strategies.
- Participate in regulatory inspections and audits.
- Contribute to the development of regulatory policies and procedures.
- Evaluate potential regulatory risks and develop mitigation strategies.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Proven experience in preparing and submitting various types of regulatory filings.
- Strong understanding of the drug development process, from preclinical to post-marketing.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Strong organizational skills and meticulous attention to detail.
- Ability to work independently and manage multiple projects in a fast-paced environment.
- Experience with regulatory information management systems is a plus.
- Professional certification (e.g., RAC) is desirable.
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2
Senior Pharmaceutical Regulatory Affairs Specialist
110001 Kanpur, Uttar Pradesh
₹1400000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a rapidly growing pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dedicated team in a fully remote capacity. This crucial role involves navigating the complex landscape of pharmaceutical regulations to ensure compliance and facilitate the timely approval of drug products globally. You will be responsible for preparing, reviewing, and submitting regulatory filings, as well as interpreting and advising on regulatory requirements across various markets. The ideal candidate possesses a strong background in pharmaceutical sciences or a related discipline, coupled with extensive experience in regulatory affairs, including INDs, NDAs, MAAs, and other global submissions. Your responsibilities will include developing regulatory strategies, managing regulatory documentation, liaising with regulatory authorities (e.g., FDA, EMA, CDSCO), staying abreast of evolving regulatory guidelines, and providing expert advice to cross-functional teams, including R&D, clinical, manufacturing, and commercial. This role requires meticulous attention to detail, exceptional analytical and problem-solving skills, and the ability to communicate complex regulatory information clearly and effectively. Proficiency in regulatory submission software and a thorough understanding of GMP, GCP, and GLP are essential. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related field is required; a Ph.D. is a plus. We are looking for a proactive, self-motivated individual who can work independently and thrive in a dynamic, remote-first environment, contributing significantly to bringing life-saving medicines to patients worldwide.
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3
Lead Pharmaceutical Regulatory Affairs Specialist
201301 Noida, Uttar Pradesh
₹120000 Annually
WhatJobs
Posted 10 days ago
Job Viewed
Job Description
Our client, a pioneering pharmaceutical company, is seeking a highly experienced and strategic Lead Pharmaceutical Regulatory Affairs Specialist to join our esteemed remote team. This crucial role involves guiding the company through the complex landscape of pharmaceutical regulations, ensuring compliance and facilitating the approval of new drug products and medical devices. You will be responsible for developing and executing regulatory strategies, preparing and submitting regulatory dossiers to health authorities worldwide, and providing expert advice on regulatory requirements. This position demands a deep understanding of global regulatory affairs, including GxP guidelines, ICH standards, and specific regional requirements. The successful candidate will manage regulatory projects, coordinate with internal teams (R&D, Clinical, Manufacturing, Quality), and interact directly with regulatory agencies. You will also stay abreast of evolving regulatory policies and their potential impact on the company's pipeline and portfolio. The ability to interpret complex regulations, provide clear guidance, and drive successful regulatory outcomes is essential. This is a remote-first position, offering flexibility and the opportunity to contribute to life-saving advancements from anywhere.
Key Responsibilities:
Key Responsibilities:
- Develop and implement comprehensive regulatory strategies for drug development and lifecycle management.
- Lead the preparation, compilation, and submission of regulatory dossiers (e.g., INDs, NDAs, MAAs, CTAs) to global health authorities.
- Serve as the primary point of contact for regulatory agencies, managing communications and addressing inquiries.
- Provide expert regulatory guidance and interpretation of guidelines to internal stakeholders across various departments.
- Monitor and analyze regulatory trends and policy changes, assessing their impact on the company and advising on strategic adjustments.
- Oversee the regulatory review process for product labeling, advertising, and promotional materials.
- Manage regulatory compliance activities, ensuring adherence to GxP, ICH, and other relevant standards.
- Lead and mentor junior regulatory affairs personnel within the remote team structure.
- Contribute to the development and continuous improvement of regulatory processes and systems.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degree (Pharm.D., Ph.D.) is a plus.
- Minimum of 8-10 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU, Japan).
- In-depth knowledge of global regulatory requirements for pharmaceuticals and biologics.
- Excellent understanding of drug development processes and GxP principles.
- Strong analytical, strategic thinking, and problem-solving skills.
- Exceptional written and verbal communication abilities, including proficiency in drafting regulatory documents.
- Demonstrated leadership and project management capabilities.
- Ability to work independently, manage priorities effectively, and collaborate across geographically dispersed teams.
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4
Senior Pharmaceutical Regulatory Affairs Specialist
380001 Ahmedabad, Gujarat
₹120000 Annually
WhatJobs
Posted 13 days ago
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Job Description
Our client is seeking a highly skilled and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their expanding team. This on-site role is integral to ensuring compliance with global regulatory requirements for pharmaceutical products. The Specialist will be responsible for preparing, reviewing, and submitting regulatory dossiers to health authorities worldwide. You will provide strategic regulatory guidance throughout the product lifecycle, from early development to post-market surveillance. Key responsibilities include staying abreast of evolving regulatory landscapes, assessing the impact of new regulations on company products and processes, and developing regulatory strategies. The ideal candidate will possess a strong understanding of pharmaceutical development, manufacturing, and quality assurance. Excellent analytical, writing, and communication skills are essential for effectively navigating complex regulatory processes and interacting with health authorities. This position requires a Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field, along with significant experience in pharmaceutical regulatory affairs. Experience with (specific region, e.g., US FDA, EMA) submissions is highly desirable. You will play a critical role in bringing innovative medicines to market and ensuring patient safety within the **Ahmedabad, Gujarat, IN** pharmaceutical ecosystem.
This advertiser has chosen not to accept applicants from your region.
5
Remote Pharmaceutical Regulatory Affairs Specialist
570001 Mysore, Karnataka
₹1000000 Annually
WhatJobs
Posted 22 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company, is seeking a dedicated Pharmaceutical Regulatory Affairs Specialist to join their team in a fully remote capacity. This role is essential for ensuring compliance with all national and international regulatory requirements for drug development and marketing. You will be responsible for preparing, submitting, and managing regulatory dossiers for new drug applications (NDAs), variations, and annual reports. Key responsibilities include staying abreast of evolving regulatory landscapes in target markets, advising R&D and commercial teams on regulatory strategies, and facilitating communication with health authorities. The ideal candidate will have a strong understanding of pharmaceutical regulations (e.g., FDA, EMA, CDSCO), a meticulous eye for detail, and proven experience in regulatory submissions. Excellent scientific acumen, strong analytical skills, and the ability to interpret complex scientific and clinical data are crucial. You will collaborate closely with cross-functional teams, including clinical development, quality assurance, and manufacturing, to ensure regulatory compliance throughout the product lifecycle. This remote position requires excellent organizational skills, strong written and verbal communication, and the ability to work independently with minimal supervision. Proactive problem-solving and a commitment to ensuring patient safety and product efficacy through robust regulatory processes are key. This is an exciting opportunity to contribute to bringing life-saving medicines to market from a remote work environment.
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6
Senior Pharmaceutical Regulatory Affairs Manager
682001 Kochi, Kerala
₹1000000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company, is seeking a highly experienced and strategic Senior Pharmaceutical Regulatory Affairs Manager to join their esteemed, fully remote team. This pivotal role will oversee and guide the company's regulatory strategy across all stages of the drug development lifecycle, ensuring compliance with global regulatory standards and facilitating the timely submission and approval of new drug applications. You will be responsible for interpreting complex regulatory guidelines, developing submission strategies, and managing interactions with health authorities worldwide. The ideal candidate possesses extensive knowledge of pharmaceutical regulations (e.g., FDA, EMA, ICH), a deep understanding of drug development processes, and a proven track record of successfully navigating regulatory pathways for diverse therapeutic areas. This is a remote-first position, requiring exceptional organizational skills, meticulous attention to detail, and strong leadership abilities to manage global regulatory projects and teams from a distance. You will lead teams in preparing and reviewing regulatory submission dossiers (e.g., INDs, NDAs, CTDs), ensuring accuracy, completeness, and adherence to all relevant guidelines. Responsibilities include advising R&D, clinical, and manufacturing departments on regulatory requirements and strategies, and proactively identifying potential regulatory challenges and developing mitigation plans. You will also monitor changes in the regulatory landscape, assess their impact on the company's pipeline, and update strategies accordingly. This role involves significant interaction with regulatory agencies, including preparing for and participating in meetings and inspections. A strong ability to build and maintain effective relationships with internal stakeholders and external regulatory bodies is essential. We are looking for a proactive, strategic thinker with outstanding communication and negotiation skills, dedicated to advancing patient access to innovative medicines. This is an exceptional opportunity to contribute to critical pharmaceutical advancements while enjoying the flexibility of a remote work environment.
Responsibilities:
Responsibilities:
- Develop and implement global regulatory affairs strategies for pharmaceutical products.
- Lead the preparation, submission, and lifecycle management of regulatory dossiers (e.g., INDs, NDAs, MAAs).
- Interpret and advise on global regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
- Manage interactions and communications with global health authorities.
- Collaborate with R&D, clinical, manufacturing, and commercial teams to ensure regulatory compliance.
- Assess the regulatory impact of new scientific findings, product changes, and market dynamics.
- Develop and maintain regulatory submission documentation and databases.
- Provide regulatory input and guidance for product development and lifecycle management.
- Mentor and manage a team of regulatory affairs professionals.
- Stay current with evolving regulatory landscapes and industry best practices.
- Advanced degree (Ph.D., Pharm.D., M.S.) in a relevant scientific discipline or equivalent experience.
- Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory requirements and submission processes for drugs and biologics.
- Proven experience in managing successful regulatory submissions and approvals.
- Strong understanding of drug development, manufacturing, and quality assurance principles.
- Excellent analytical, strategic thinking, and problem-solving skills.
- Exceptional written and verbal communication skills, with strong presentation abilities.
- Demonstrated leadership and team management experience.
- Ability to work independently and manage multiple priorities in a remote setting.
- Experience with regulatory information management (RIM) systems is a plus.
This advertiser has chosen not to accept applicants from your region.
7
Senior Pharmaceutical Regulatory Affairs Manager
110001 Delhi, Delhi
₹1400000 Annually
WhatJobs
Posted 13 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly competent Senior Pharmaceutical Regulatory Affairs Manager to join their team in Delhi, Delhi, IN . This critical role involves managing and overseeing all aspects of regulatory submissions and compliance for pharmaceutical products. You will be responsible for developing and implementing regulatory strategies to ensure timely approval of new drug applications (NDAs) and variations, as well as maintaining compliance with global regulatory requirements. Key responsibilities include preparing and submitting regulatory documentation to health authorities, responding to queries from regulatory agencies, and monitoring changes in global regulatory landscapes. You will also collaborate closely with R&D, clinical affairs, manufacturing, and marketing departments to ensure regulatory requirements are met throughout the product lifecycle. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Science, or a related field, with a minimum of 6-8 years of experience in pharmaceutical regulatory affairs. A strong understanding of ICH guidelines, GMP, and regulatory submission processes in various regions is essential. Excellent analytical, problem-solving, and project management skills are required. The ability to lead cross-functional teams and communicate effectively with both internal stakeholders and external regulatory bodies is paramount. This is an exceptional opportunity for a dedicated professional to contribute to bringing life-saving medicines to market and advancing their career within a reputable organization.
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8
Senior Pharmaceutical Regulatory Affairs Manager
530001 Visakhapatnam, Andhra Pradesh
₹2000000 Annually
WhatJobs
Posted 15 days ago
Job Viewed
Job Description
Join our innovative and rapidly growing pharmaceutical company as a Senior Pharmaceutical Regulatory Affairs Manager. This is a fully remote position, offering you the flexibility to work from your preferred location within India while contributing to critical global health initiatives. You will be responsible for leading and managing all aspects of regulatory affairs, ensuring compliance with national and international regulatory requirements for our pharmaceutical products. This role demands a deep understanding of regulatory landscapes, strong strategic thinking, and excellent communication skills.
Key Responsibilities:
Qualifications and Experience:
Key Responsibilities:
- Develop and execute global regulatory strategies for new drug applications (NDAs), investigational new drug applications (INDs), and other regulatory submissions.
- Oversee the preparation, review, and submission of high-quality regulatory documents to health authorities worldwide (e.g., US FDA, EMA, CDSCO).
- Liaise directly with regulatory agencies, manage communications, and respond to queries and requests for information.
- Ensure compliance with all applicable regulatory guidelines, GxP standards, and company policies throughout the product lifecycle.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical operations, manufacturing, and quality assurance.
- Monitor and interpret evolving regulatory requirements and advise the organization on potential impacts and necessary actions.
- Manage and mentor a team of regulatory affairs professionals, fostering their growth and ensuring efficient workflow.
- Conduct regulatory intelligence activities to identify emerging trends and opportunities.
- Participate in strategic planning and contribute to the overall business objectives of the company from a regulatory perspective.
- Lead regulatory due diligence activities for potential business development opportunities.
Qualifications and Experience:
- Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 10-15 years of progressive experience in pharmaceutical regulatory affairs.
- Extensive experience in preparing and submitting regulatory dossiers for various dosage forms and therapeutic areas.
- In-depth knowledge of global regulatory guidelines and submission processes (e.g., ICH, CTD).
- Proven experience in interacting with major health authorities (FDA, EMA, etc.).
- Strong leadership, project management, and organizational skills.
- Excellent written and verbal communication skills, with meticulous attention to detail.
- Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines in a remote environment.
- Demonstrated ability to influence cross-functional teams and senior management.
This advertiser has chosen not to accept applicants from your region.
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