Bayer is a global leader in life sciences, committed to solving some of the world’s toughest challenges in health and agriculture. With a vision of “Health for all, Hunger for none,” Bayer strives to make this vision a reality through innovation, dedication, and collaboration. At Bayer, you will join a diverse community of brilliant minds working together to redefine what’s possible in healthcare and pharmaceuticals.
Job Title: Regulatory Affairs Specialist
Job Description
Bayer is seeking a Regulatory Affairs Specialist to join its Pharmaceuticals division in Thane, Maharashtra. This role is critical for managing all regulatory affairs activities within the assigned portfolio and geography, ensuring compliance with local and international health authorities.
Key Responsibilities:
- Lead regulatory submissions, approvals, and licensing activities for pharmaceutical (Rx) and medical device products.
- Develop and execute regulatory strategies aligned with business goals.
- Manage lifecycle regulatory activities including renewals, change management, and compliance monitoring.
- Collaborate cross-functionally with local, regional, and global teams to ensure timely product registrations and label approvals.
- Build and maintain strong relationships with health authorities and government bodies.
- Ensure compliance with all regulatory, corporate, and legal policies throughout the product lifecycle.
- Support the Head of RA PH-South Asia in process improvements, SOP development, and governance.
- Oversee maintenance of licenses such as GMP certificates and manufacturing licenses.
Who Should Apply?
- Post-graduate in Life Sciences (preferably Pharmacy) with at least 3 years of experience in pharmaceutical regulatory affairs.
- Proven track record in health authority interactions, regulatory submissions, and approvals.
- Strong knowledge of CMC and clinical regulatory requirements in India.
- Experience with local manufacturing and export markets (Nepal, Bangladesh, Sri Lanka) is a plus.
- Excellent communication, negotiation, and project management skills.
- Ability to analyze complex regulatory scenarios and propose risk mitigation strategies.
- Familiarity with global regulatory frameworks (EU, US, ICH, GCP, GMP) is highly desirable.
Why Join Bayer?
- Work with a global leader in pharmaceuticals committed to innovation and sustainability.
- Be part of a diverse and inclusive workplace that values fairness and respect.
- Opportunity to grow your career in a dynamic and challenging environment.
- Contribute to meaningful projects that impact health and wellbeing worldwide.
