Regulatory Affairs Job at Boehringer Ingelheim
Looking for a Regulatory Affairs Job with a global biopharmaceutical company? Boehringer Ingelheim Careers has an opening for a Manager – Regulatory Affairs in Mumbai. Candidates with a pharmacy or similar medical education and 4–6 years of pharmaceutical regulatory experience can apply. Among specialized Medical Jobs India, this role offers opportunities to manage regulatory submissions, product registrations, compliance, health authority interactions and cross-functional regulatory strategy.
About Boehringer Ingelheim:
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. The company employs approximately 54,300 individuals and serves over 130 markets to build a healthier and more sustainable tomorrow.
Job Details:
- Position: Manager – Regulatory Affairs
- Job ID: 36901
- Location: Mumbai
- Function: Regulatory Affairs
Job Description:
This Regulatory Affairs Jobs opportunity is for a Manager – Regulatory Affairs at Boehringer Ingelheim in Mumbai. The selected professional will lead and execute local regulatory activities aligned with regional strategies and business priorities. Responsibilities include regulatory dossier preparation, maintaining product registrations and marketing authorizations, monitoring regulatory changes and working with health authorities and cross-functional stakeholders to support product availability, launches and business objectives.
Key Responsibilities:
- Execute regulatory activities on time and in line with META strategies and local business priorities.
- Prepare, compile, and submit regulatory dossiers in accordance with local regulations and requirements.
- Maintain product registrations and marketing authorizations to ensure uninterrupted product availability.
- Support product shipments and ensure regulatory documentation remains current and compliant.
- Manage and maintain regulatory databases, records, acknowledgments, and filing systems.
- Monitor changes in the regulatory environment and provide insights on emerging requirements, industry trends, competitor activities, risks, and opportunities.
- Build strong relationships with health authorities, local agents, vendors, and regulatory service providers.
- Participate actively in brand team discussions and contribute regulatory expertise to support business objectives.
Eligibility Criteria for this Regulatory Affairs Job:
- Bachelor’s degree in pharmacy or similar medical education.
- Pharma experience with regulatory focus in a multi-national for at least 4-6 years.
- Experience of direct interactions with Regulatory Authorities.
- Prior people management experience is an asset.
- Demonstrating RA knowledge, critical thinking, and problem-solving skills.
- Effective negotiation and communication skills.
- Solid understanding of D&C Act and Rules.
- Position is based at Mumbai.
Skills Required for this Regulatory Affairs Job:
- Regulatory Affairs & Compliance Expertise
- Regulatory Dossier Preparation & Submission
- Product Registration & Marketing Authorization
- Drugs & Cosmetics Act and Rules Knowledge
- Health Authority Interaction & Stakeholder Management
- Regulatory Intelligence & Risk Assessment
- Critical Thinking, Problem-Solving & Negotiation
- Cross-Functional Communication & Leadership
