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Join Bayer as a Regulatory Affairs Specialist and play a critical role in shaping regulatory strategies that align with business goals and global standards. In this pharma role, you’ll manage submissions, approvals, and compliance processes across pharmaceuticals and medical devices while ensuring timely licensing and governance. With opportunities to collaborate cross-functionally and influence health authority interactions, this role empowers you to contribute to Bayer’s vision of “Health for all, Hunger for none.”
- Position: Regulatory Affairs Specialist
- Location: Maharashtra, Thane
- Division: Pharmaceuticals
- Reference Code: 852872
About Bayer
Bayer is a global pharmaceutical and life sciences company committed to improving human and animal health. We focus on developing innovative products to address some of the world’s most significant health challenges.
Qualification
Post-graduates in Pharmacy
Experience
Minimum of 3 years of pharmaceutical industry experience in regulatory affairs with a proven track record and experience in health authority interactions and negotiations, end-to-end regulatory submissions and approvals across various therapeutic areas and categories. Demonstrated track record of providing workable solutions to complex regulatory topics.
Position Purpose
The Regulatory Affairs Specialist at Bayer Pharma (PH) is responsible for all regulatory affairs activities within the assigned portfolio and/or geography. They work closely with the Head of RA PH-South Asia to plan, develop, and execute regulatory strategies in alignment with business goals and ensure compliance with all relevant regulations.
Roles and Responsibilities
- Plan, develop, and execute regulatory submissions and approvals for the assigned PH portfolio
- Conduct regulatory probability assessments for optimal business planning
- Build relationships with Health Authorities and government bodies
- Maintain compliance with regulatory requirements and ensure no supply disruptions
- Support the development and implementation of regulatory processes and systems
Who You Are
You should have excellent communication skills, analytical abilities, and the capacity to work effectively in a dynamic environment.
Why Apply at Bayer
Joining Bayer as a Regulatory Affairs Specialist offers the opportunity to shape regulatory strategies that directly impact patient health and business growth. You will play a vital role in ensuring compliance, managing submissions, and building strong partnerships with health authorities, all while working on innovative pharmaceutical and medical device portfolios. At Bayer, you will be part of a diverse, inclusive, and global community committed to “Health for all, Hunger for none.” This role provides a platform for career growth, cross-functional collaboration, and contributing to solutions that make a real difference worldwide.
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