Regulatory Affairs Specialist – Pharmaceuticals
Location: Thane, Maharashtra, India
Division: Pharmaceuticals
Reference Code: 852872
About Bayer
At Bayer, we are visionaries committed to solving the world’s toughest challenges. Our mission – "Health for all, Hunger for none" – fuels our passion and purpose. We work with energy, curiosity, and dedication to make the impossible, possible.
We value diverse perspectives and continuous learning. If you're seeking a meaningful and varied career in a collaborative and innovative environment, Bayer is your destination.
Position Purpose
As a Regulatory Affairs Specialist, you will be responsible and accountable for all regulatory activities related to Bayer's Pharma (PH) portfolio within your assigned geography or therapeutic scope. This includes regulatory planning, submission, maintenance, compliance, and governance of pharmaceuticals (Rx) and medical devices, ensuring alignment with Bayer’s business strategies and local health authority requirements.
You will act as a functional leader, aligning regulatory strategies with business goals through strong cross-functional collaboration and stakeholder engagement.
Key Responsibilities
Regulatory Planning & Execution
Plan, develop, and execute regulatory submissions and approvals for assigned Pharma portfolio.
Ensure regulatory activities support business strategies, brand value, and market access.
Assess regulatory probabilities and timelines for optimal business planning.
Health Authority (HA) Interactions
Build and maintain trust-based relationships with Health Authorities and government bodies.
Engage in regulatory negotiations and represent Bayer in regulatory interactions.
Compliance & Governance
Ensure product compliance with all applicable regulations and Bayer’s internal policies throughout the product lifecycle.
Maintain critical licenses (e.g. GMP certificates, manufacturing licenses, etc.).
Support the development and implementation of local regulatory SOPs, systems, and processes.
Lifecycle Management
Supervise lifecycle management activities (e.g. renewals, change management, CMC variations).
Ensure timely regulatory maintenance of locally manufactured and imported products, including those for export (Nepal, Bangladesh, Sri Lanka, etc.).
Cross-functional Collaboration
Work closely with commercial, supply chain, legal, medical affairs, and regional/global regulatory teams to ensure aligned regulatory outcomes.
Contribute to internal governance, KPIs, and performance metrics.
Promotional & Labeling Compliance
Review and approve product labeling and promotional materials for regulatory compliance.
Secure and maintain compliant product labels across the portfolio.
Who You Are
Education & Experience
Postgraduate degree in Life Sciences (preferably Pharmacy)
Minimum 3 years’ experience in regulatory affairs in the pharmaceutical industry
Proven experience in health authority interactions and regulatory submissions across therapeutic areas
Technical Expertise
Strong knowledge of CMC and clinical regulatory requirements in India
Experience with locally manufactured products and exports to neighboring countries
Understanding of global regulatory frameworks (EU, US, ICH, GCP, GMP)
Core Competencies
Strong analytical and problem-solving skills
Excellent interpersonal and communication abilities (written and verbal)
Effective stakeholder management and negotiation skills
Ability to manage multiple projects and timelines under pressure
High standards of compliance, ethics, and governance
Self-motivated with a proactive mindset; able to work both independently and in teams
Why Bayer?
At Bayer, we’re more than just a workplace—we’re a community of bold thinkers shaping the future of health and nutrition. You'll work in a dynamic environment where innovation, diversity, and inclusion are embedded in everything we do.
Equal Opportunity Employer
Bayer is an equal opportunity employer. We are committed to creating an inclusive work environment and treat all applicants fairly, regardless of race, religion, gender, age, disability, or sexual orientation.
Contact Us
📞 Phone: +91 22-25311234
🌐 Learn more about our vision and strategy at: https://www.bayer.com/en/strategy/strategy
If you're ready to make an impact through regulatory excellence, apply now and grow with Bayer!
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