Life Science Job at Bayer – Apply Now for the Regulatory Affairs Specialist Role!
Bayer Pharma is seeking a skilled Regulatory Affairs Specialist in Thane, Maharashtra, to manage regulatory submissions, approvals, and compliance for its pharmaceutical portfolio. This Life Science Job at Bayer ensures seamless alignment between business objectives and regulatory strategies, enabling timely product launches, lifecycle management, and robust engagement with health authorities.
Job Details:
- Location: Thane, Maharashtra, India
- Division: Pharmaceuticals
- Reference Code: 852872
- Employment Type: Full-time
Position Purpose:
The Regulatory Affairs Specialist role will lead regulatory activities for Bayer Pharma within the assigned portfolio and geography. Reporting to the Head of RA PH-South Asia. The role ensures effective planning, development, and execution of regulatory strategies aligned with business goals. Responsibilities in this Life Science Job at Bayer will include licensing activities for imported, local, and export products, as well as compliance with pharmaceutical and medical device regulations. The specialist may supervise junior RA staff and manage lifecycle activities, ensuring timely registration of new chemical/biological entities (NCE/NBE), new indications, and line extensions.
About the Company:
Bayer Pharma is a global leader in pharmaceuticals committed to innovation, patient safety, and regulatory excellence. The company promotes a diverse and inclusive work environment, valuing fairness, respect, and equal opportunity for all applicants.
Educational Requirements:
- Post-graduate in Life Sciences, preferably Pharmacy
- Minimum 3 years of experience in pharmaceutical regulatory affairs
- Proven track record in regulatory submissions, approvals, and health authority interactions
Key Responsibilities:
- Plan, develop, and execute regulatory submissions and approvals for assigned portfolio
- Conduct regulatory probability assessments for strategic business planning
- Build and maintain relationships with Health Authorities and government bodies
- Ensure compliance with all regulatory requirements throughout product lifecycle
- Support development and implementation of RA processes, SOPs, and systems
- Participate in product labeling and promotional material review
- Analyze complex regulatory challenges and propose solutions and risk mitigation strategies
- Maintain necessary licenses, GMP certificates, and other regulatory permits
Skills Required:
- Strong knowledge of CMC, clinical aspects, and regulatory submissions
- Experience with locally manufactured products and exports to neighboring countries
- Excellent communication and negotiation skills
- Project management and multi-tasking ability under time pressure
- Analytical skills for assessing regulatory situations and future trends
- Familiarity with global regulatory frameworks (EU, US, ICH, GCP, GMP)
- Self-starter with ability to influence and collaborate cross-functionally
How to Apply?
Interested candidates can contact Bayer at +022-25311234 for inquiries. Bayer welcomes applications from all individuals regardless of race, religion, gender, age, disability, or sexual orientation.
