Regulatory Affairs Job at Bayer | MSc Graduates Apply Online
Join Bayer, a global leader in life sciences and pharmaceuticals, as a Regulatory Affairs Specialist in Thane, Maharashtra. In this Regulatory Affairs Job, you will manage regulatory submissions, compliance, and product lifecycle activities for Bayer’s pharmaceutical portfolio. If you’re passionate about navigating global regulations and driving patient-focused innovation, this Pharmacy Job is your chance to make a real impact.
- Job Post: Regulatory Affairs Specialist
- Location: Thane, Maharashtra, India
- Job ID: 852872
About Bayer:
At Bayer, we strive to build a world where Health for All, Hunger for None. With innovation, curiosity, and collaboration, we develop cutting-edge healthcare solutions to solve global challenges. Working at Bayer means being part of a visionary company dedicated to science, sustainability, and human progress.
Regulatory Affairs Job Purpose:
The Regulatory Affairs Specialist is responsible for leading and executing all regulatory affairs activities for Bayer Pharma within assigned portfolios and geographies. The role ensures timely product registrations, compliance with global and local regulations, and strategic alignment with business objectives.
Key Responsibilities of the Pharmacy Job:
- Plan, develop, and execute regulatory submissions and approvals in alignment with corporate goals.
- Manage licensing activities, including renewals, CMC changes, and export registrations.
- Ensure compliance with local and international regulatory requirements throughout the product lifecycle.
- Support the development and implementation of SOPs, systems, and compliance processes.
- Maintain and update product licenses, GMP certifications, and other regulatory documentation.
- Liaise with Health Authorities and government agencies for submissions, renewals, and inspections.
- Review and approve promotional materials and product labeling for compliance.
- Train and guide junior RA team members when necessary.
- Support cross-functional collaboration between Regulatory Affairs, QA, Manufacturing, and Commercial teams.
Education and Experience for Regulatory Affairs Job:
- Postgraduate in Pharmacy (preferred).
- Minimum 3 years of experience in Regulatory Affairs in the pharmaceutical industry.
- Proven experience in regulatory submissions, approvals, and health authority interactions.
- Strong understanding of CMC, clinical documentation, and compliance standards.
- Experience with locally manufactured products and exports to Nepal, Bangladesh, or Sri Lanka is a plus.
- Excellent communication and negotiation skills with the ability to influence stakeholders.
- Analytical, proactive, and capable of handling multiple priorities effectively.
- Fluency in English (written and spoken).
- Knowledge of global regulatory frameworks (ICH, GCP, GMP, EU, US FDA) preferred.
Core Competencies:
- Regulatory Strategy & Compliance
- Product Lifecycle Management
- Health Authority Communication
- Documentation & Data Integrity
- Cross-functional Collaboration
- Risk Assessment & Mitigation
- Project Management
Why Join Bayer:
- Work with a global leader in healthcare and pharmaceuticals.
- Be part of a diverse, inclusive, and collaborative culture.
- Competitive salary and benefits.
- Opportunities for career growth and international exposure.
- Commitment to sustainability, ethics, and innovation.
