PHARMAFull-time
Manager Regulatory Affairs - Delhi
DELHI NCR (IN)ONSITEPOSTED: 9/26/2026
PHARMAFull-time
HIRING ORGANIZATIONBOEHRINGER INGELHEIMBiopharmaceuticals / Pharmaceuticals
ROLE OVERVIEW
Regulatory Affairs Manager responsible for product registrations, regulatory submissions, approvals, renewals, CMC changes and regulatory intelligence for assigned therapeutic areas in India.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage registration of NCEs and line extensions for assigned therapeutic areas
- •Develop regulatory strategies compliant with applicable regulations
- •Liaise with Health Authorities and support timely submissions and registrations
- •Follow up regulatory approvals according to registration plans
- •Engage with senior regulatory officials and maintain effective Health Authority relationships
- •Coordinate submissions and approvals for CMC changes in line with global timelines
- •Ensure timely product renewals to maintain uninterrupted availability
- •Manage amendments, study-related updates and required notifications
- •Follow up submitted applications with Health Authorities
- •Monitor regulatory developments and communicate relevant updates to local and global teams
- •Maintain regulatory intelligence entries and impact assessments in the RINTOOL/RIN database
Reporting Hierarchy: Reports to the relevant Regulatory Affairs leadership; works closely with local and global regulatory teams and Health Authorities
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in Pharmacy or similar medical/scientific education
- 8-10 years of pharmaceutical experience with a regulatory focus
- Experience working in a multinational pharmaceutical environment
- Proven Health Authority liaison experience
- Strong understanding of the Drugs and Cosmetics Act and Rules
- Experience directly interacting with Regulatory Authorities
- Strong analytical, communication and negotiation skills
PREFERRED QUALIFICATIONS
- •Experience managing NCE registrations and line extensions
- •CMC regulatory change experience
- •Regulatory intelligence experience
- •Experience with RINTOOL/RIN database
- •Strong established relationships with Health Authorities
REQUIRED VERIFIED SKILLS
Regulatory Affairs
NCE registration
line extensions
regulatory submissions
Health Authority liaison
regulatory approvals
CMC changes
product renewals
regulatory amendments
regulatory intelligence
RINTOOL
RIN database
Drugs and Cosmetics Act
Drugs and Cosmetics Rules
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health and wellbeing programs, professional development opportunities, employee support programs and other benefits applicable under company policy
No salary or bonus/equity information is disclosed in the supplied posting. Compensation should be evaluated from the actual employer offer and applicable India market benchmarks rather than inferred.
ORGANIZATION CONTEXT & CULTURE
Boehringer Ingelheim is a global biopharmaceutical company focused on human and animal health. Founded in 1885, it operates independently and invests heavily in research and development for innovative therapies.
TEAM SIZE: 54,300+ employees
INDUSTRY: Biopharmaceuticals / Pharmaceuticals
Culture: Boehringer Ingelheim emphasizes innovation, employee development, inclusion, respect, wellbeing and long-term commitment to healthcare.
EXPECTED CAREER ROADMAP
The role can progress toward Senior Regulatory Affairs Manager, Associate Director/Director Regulatory Affairs and broader regional or global regulatory leadership positions, depending on performance and organizational structure.
APPLICATION ADVISORY
Emphasize 8-10+ years of pharmaceutical regulatory experience; highlight direct Health Authority interactions and successful submissions/approvals; demonstrate NCE, line-extension, renewal and CMC change experience; mention knowledge of the Drugs and Cosmetics Act and Rules; showcase regulatory intelligence and stakeholder negotiation skills.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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