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66 Regulatory Affairs Specialists jobs in Bangalore

Regulatory Affairs Manager

Bangalore, Karnataka ThermoFisher Scientific

Posted 5 days ago

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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.

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Mgr Regulatory Affairs

Bangalore, Karnataka Teva Pharmaceuticals

Posted 5 days ago

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Job Description

Mgr Regulatory Affairs
Date: Oct 4, 2025
Location:
Bangalore, India,
Company: Teva Pharmaceuticals
Job Id: 63860
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
+ Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company.
+ Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases.
+ Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.
.
**How you'll spend your day**
Regulatory Submissions
+ Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region.
+ Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.
+ Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)
Regulatory Intelligence/Expertise/Guidance/Education
+ Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities
+ Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams.
+ Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.
+ Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.
+ Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.
+ Work closely with market RA in APAC region to complete all assigned activities
**Your experience and qualifications**
+ B. Pharm / M. Pharm (preferred) with 10+ years of experience
+ Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.
+ Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran

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Regulatory Affairs Specialist

Bengaluru, Karnataka Biocon Biologics

Posted 1 day ago

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Job Description

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:

• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio

• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products

• Collaboration with partners to develop and execute global regulatory activities

• DMF preparations, review of changes and routine updates to Global Regulatory Agencies

• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution

• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements

• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle

• Support development and execution of clinical/non-clinical strategies

• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration

• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans

• With minimal supervision, participate in development of risk management and contingency planning

• Ensure and lead regulatory compliance for biosimilar products

• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:

• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

• Review and assess impact of regulatory decisions for competitive products

• Generate and communicate biosimilar intelligence Collaboration:

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

• Identify process needs to meet internal challenges

• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and

Skills

• Comprehensive understanding of Regulatory activities

• Regulatory experience with product filings

• Team skills, especially in working with internal and external partners

• Familiarity with project management requirements

• Ability to understand and communicate scientific CMC information

• Anticipate and prevent potential issues

• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education

Doctorate degree OR Master's degree

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Regulatory Affairs Specialist

Bengaluru, Karnataka Biocon Biologics

Posted today

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Job Description

Job Summary:
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:
• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
• Collaboration with partners to develop and execute global regulatory activities
• DMF preparations, review of changes and routine updates to Global Regulatory Agencies
• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution
• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
• Support development and execution of clinical/non-clinical strategies
• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
• With minimal supervision, participate in development of risk management and contingency planning
• Ensure and lead regulatory compliance for biosimilar products
• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:
• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products
• Review and assess impact of regulatory decisions for competitive products
• Generate and communicate biosimilar intelligence Collaboration:
• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
• Identify process needs to meet internal challenges
• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and

Skills
• Comprehensive understanding of Regulatory activities
• Regulatory experience with product filings
• Team skills, especially in working with internal and external partners
• Familiarity with project management requirements
• Ability to understand and communicate scientific CMC information
• Anticipate and prevent potential issues
• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education
Doctorate degree OR Master's degree

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Regulatory Affairs Manager

Bengaluru, Karnataka beBeeCompliance

Posted today

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Job Description

About this Compliance Role:

We are seeking a skilled professional to support our regulatory requirements in India and international countries.

Key responsibilities include applying for and renewing licenses and certifications, arranging phytosanitary inspections, and coordinating with laboratories and quarantine officers.

Additionally, you will provide guidance on country-specific product classification, maintain a compliance tracker for each product and destination country, and ensure smooth coordination with government departments and testing labs.

What We Are Looking For:

To be successful in this role, you will need 3–6 years of experience in regulatory affairs, preferably in pharma, Ayurveda, or export compliance. You should also have a strong understanding of regulatory filings for African/CIS countries.

Able to work remotely and independently while managing communication with labs, certification bodies, and government departments, you will possess excellent organizational and documentation skills.

A Great Opportunity:

This role offers a chance to make a significant impact on our compliance efforts and work with a dynamic team.

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Regulatory Affairs Specialist

Goa, Goa UpMan Placements

Posted today

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Job Description

Core Job Responsibilities:

Regulatory Submissions and compliance

Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
Ensure timely submissions and approvals for all regulatory filings.
Evaluate technical and scientific data for regulatory submissions.
Liaise with health authorities for inspections, clarifications, and approvals.
Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.

Product & Business Support

Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
Provide regulatory support for internalization and externalization of products.
To provide site CMC documents to international business team to support export registration.

Documentation & Quality Oversight

Maintain and update regulatory databases, trackers, licenses, and approvals.
Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
Evaluate and approve site change controls and Change Request evaluation forms.
Provide working standards/specifications and CoAs to regulatory authorities and internal teams.

Tender Certificates

To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.

Governance, SOPs & Training

Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
Deliver training on GMP, regulatory updates, and SOPs at the site level.
Approve SCNs from Corporate QA and review reports from regulatory authorities.

Additional Responsibilities

Complete assigned trainings on time
Perform other duties as assigned by the Regulatory Affairs leadership.
Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.

Position Accountability/Scope:

· Responsible for all regulatory activities for the manufacturing site mainly LL sites.
· Ensures site compliance with applicable national regulations and Abbott standards.
Supports business continuity through proactive regulatory planning and execution.

Minimum Education:

B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

Minimum Experience/Training Required:

GOA FDA Mandatory
Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.

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Regulatory Affairs Specialist

Bangalore, Karnataka Biocon Biologics