Pharma Jobs in Maharashtra: Bayer is Hiring a Regulatory Affairs Specialist
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Looking for Pharma Jobs in Maharashtra? Bayer is hiring a Regulatory Affairs Specialist to manage end-to-end regulatory submissions, approvals, and compliance for pharmaceutical and medical device products. This role is ideal for pharmacy and life sciences professionals with regulatory experience, offering an opportunity to work in a dynamic, highly regulated environment while contributing to Bayer’s mission of “Health for all, Hunger for none.”
Job Details:
- Job Title: Regulatory Affairs Specialist
- Location: Thane, Maharashtra, India
- Employment Type: Full-time
About Bayer:
Bayer is a global life sciences company committed to improving health and quality of life worldwide. With a focus on pharmaceuticals, consumer health, and crop science, Bayer drives innovation to address some of the world’s toughest challenges. The company is guided by its purpose: “Health for all, Hunger for none,” striving to make this vision a reality through energy, curiosity, and dedication. A career at Bayer offers professionals opportunities to work in a dynamic, highly regulated environment, engage in cross-functional collaboration, and contribute to meaningful projects.
Education:
Post-graduate in Life Sciences or Pharmacy.
Experience:
Minimum 3 years’ experience in pharmaceutical regulatory affairs.
Key Responsibilities:
- Plan, develop, and execute regulatory strategies for the assigned portfolio.
- Manage licensing activities for local, imported, and export products.
- Ensure regulatory compliance throughout the product lifecycle.
- Supervise junior RA staff in Lifecycle Management activities when required.
- Maintain relationships with Health Authorities and government bodies to achieve business goals.
- Support Head of RA PH-South Asia in process and SOP development.
- Secure and maintain product licenses, labeling, and participate in promotional material review.
- Conduct regulatory probability assessments for approvals and milestones.
- Provide regulatory input for new chemical/biological entities, line extensions, and new indications.
Skills:
- Proven track record in regulatory submissions, approvals, and Health Authority interactions.
- Knowledge of CMC and clinical aspects for regulatory submissions.
- Experience with local manufacturing and exports (Nepal, Bangladesh, Sri Lanka) preferred.
- Strong analytical, project management, and communication skills.
