Bayer Pharma is seeking a highly motivated and experienced Regulatory Affairs Specialist to join their team in India. As a key member of the regulatory affairs team, you will play a critical role in planning, developing, and executing regulatory strategies for assigned portfolios and geographies.
🔹About the Role
Job Title: Regulatory Affairs Specialist
Location: India
Experience: 3+ years in regulatory affairs with a proven track record
Job Type: Full-time
🧩Responsibilities
Regulatory Strategy and Planning: Develop and execute regulatory strategies for assigned portfolios and geographies, ensuring alignment with business goals and plans.
Regulatory Submissions and Approvals: Plan, develop, and execute regulatory submissions and approvals for pharmaceutical products, including new chemical/biological entities, new indications, and line extensions.
Compliance and Governance: Ensure compliance with all relevant regulatory requirements, corporate policies, and local regulations throughout the product life cycle.
Stakeholder Management: Establish and maintain relationships with health authorities and other relevant government bodies, ensuring compliance with applicable regulatory requirements.
Cross-Functional Collaboration: Work closely with cross-functional teams, including regulatory affairs, to deliver optimal company outcomes.
🎓Requirements
Education: Post-graduate degree in Life Sciences (preferably Pharmacy) with a minimum of 3 years of experience in regulatory affairs.
Experience: Proven track record in regulatory affairs, including health authority interactions, negotiations, and end-to-end regulatory submissions and approvals.
Skills:
Strong understanding of regulatory requirements, including CMC and clinical aspects.
Excellent interpersonal and communication skills.
Ability to assess complex situations and propose solutions.
Good project management skills to organise and prioritise diverse activities.
Solid knowledge of compliance aspects related to regulatory affairs.
💼What We Offer
Career Growth: Opportunities for professional growth and development within a leading pharmaceutical company.
Collaborative Environment: Dynamic and supportive team environment that encourages innovation and creativity.
Competitive Benefits: Attractive salary and benefits package.
🚀 Ready to Make an Impact?
If you’re a motivated Regulatory Affairs professional eager to make a difference in the pharmaceutical industry, apply now and join the Bayer Pharma team!
👉 Apply Here: https://jobs.bayer.com/job-invite/852872/