Regulatory Affairs Jobs In Pharma: Bayer is Hiring in Thane, Maharashtra
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Want to contribute to the Pharma Industry and looking for Regulatory Affairs Jobs In Pharma Join? Bayer as a Regulatory Affairs Specialist and play a pivotal role in ensuring compliance and excellence in pharmaceutical regulatory operations. This position involves overseeing all licensing activities, developing and executing regulatory strategies, and maintaining alignment with business goals. As part of Bayer’s commitment to innovation and ethical practices, you will collaborate cross-functionally to drive regulatory success and maintain product compliance across diverse markets.
Job Details:
- Job Title: Regulatory Affairs Specialist
- Location: Thane, Maharashtra, India
- Division: Pharmaceuticals
- Reference Code: 852872
Position Purpose:
Responsible and accountable for all regulatory affairs activities of Bayer Pharma (PH) within the assigned portfolio and geography. In alignment with the Head of RA PH-South Asia, provide effective leadership and governance in developing and executing regulatory strategies that support business growth and compliance. Activities include licensing, maintenance, and change management for imported, local, and export products, coordinating with Health Authorities and government bodies related to pharmaceuticals and medical devices.
The position ensures best regulatory planning for all new chemical/biological entities, new indications, and line extensions, maintaining compliance across the entire product life cycle. It also involves mentoring junior staff, ensuring governance, and implementing best practices in line with Bayer’s global regulatory standards.
About the Company:
Bayer is a global life sciences leader with a strong focus on healthcare and agriculture. Headquartered in Leverkusen, Germany, Bayer’s mission — “Science for a Better Life” — reflects its dedication to improving human health and advancing sustainable solutions through innovation and research. Within the Pharmaceuticals Division, Bayer is recognized for developing breakthrough therapies that address key health challenges in areas such as cardiology, oncology, women’s health, hematology, and ophthalmology. The company combines scientific excellence with a patient-centric approach to deliver high-quality and effective medicines worldwide. In India, Bayer operates with a deep commitment to regulatory excellence, ethical practices, and quality compliance. The company collaborates closely with healthcare professionals, government bodies, and global stakeholders to ensure the availability of safe and effective medicines.
Education Requirements:
Post-graduate in Life Sciences (preferably Pharmacy) with at least 3 years of experience in pharmaceutical regulatory affairs.
Key Responsibilities:
- Plan, develop, and execute regulatory submissions and approvals to achieve business objectives.
- Conduct regulatory probability assessments for optimal planning.
- Build strong relationships with Health Authorities based on trust and transparency.
- Maintain full compliance to prevent supply disruptions.
- Support Head of RA PH-South Asia in developing and implementing SOPs and systems.
- Ensure compliant product licenses, labeling, and promotional material review.
Skills:
- Proven expertise in health authority interactions, end-to-end submissions, and licensing.
- Strong understanding of CMC, clinical aspects, and regulatory submissions.
- Experience with locally manufactured products and exports to South Asian countries.
- Excellent communication, analytical, and project management skills.
- Fluent in English with strong negotiation and interpersonal skills.
- In-depth knowledge of compliance, GCP, GMP, and ICH guidelines.
