Regulatory Affairs Specialist
Location: Thane, Maharashtra, India
Division: Pharmaceuticals
Reference Code: 852872
Position Purpose
The Regulatory Affairs Specialist is responsible for managing and executing all regulatory affairs activities within the assigned Bayer Pharma portfolio and/or geography. This includes:
Providing functional leadership and governance in regulatory planning and strategy aligned with business objectives
Managing licensing, maintenance, and change management for imported, local, and export-market products (pharmaceuticals and medical devices)
Supervising junior RA staff for lifecycle management activities (renewals, CMCs) when required
Ensuring timely registration and label compliance for new chemical/biological entities (NCE/NBE), new indications, and line extensions
Maintaining full awareness of all regulatory activities and deadlines for assigned portfolio
Ensuring products comply with regulatory, corporate, legal, and local requirements throughout the product lifecycle
Working closely with local, regional, and global stakeholders to achieve optimal outcomes
Maintaining required licenses for company functioning (e.g., GMP certificate, manufacturing license)
Key Responsibilities
Regulatory Strategy & Compliance
Plan, develop, and execute regulatory submissions and approvals for the assigned portfolio
Conduct regulatory probability assessments for approvals and Health Authority review milestones
Maintain compliance with all regulatory requirements to prevent supply disruptions
Secure and maintain product licenses, labelling compliance, and participate in promotional material review/approval
Support Head of RA PH-South Asia in SOPs, processes, and systems development
Health Authority & Stakeholder Engagement
Build and maintain relationships with Health Authorities and government bodies based on trust, transparency, and partnership
Provide input on regulatory probability assessments and anticipate regulatory changes
Act as a business partner to commercial organizations and cross-functional teams
Risk Management & Process Improvement
Analyze complex regulatory situations and propose risk mitigation strategies
Monitor processes for compliance and governance; develop best practices for team adoption
Lead junior RA staff when required for lifecycle management activities
Qualifications & Experience
Postgraduate degree in Life Sciences (preferably Pharmacy)
Minimum 3 years of pharmaceutical industry experience in regulatory affairs
Proven track record in:
Health authority interactions and negotiations
End-to-end regulatory submissions and approvals across therapeutic areas
Providing solutions to complex regulatory challenges
In-depth knowledge of CMC and clinical aspects for regulatory submissions
Experience with locally manufactured products and exports (e.g., Nepal, Bangladesh, Sri Lanka) is highly desirable
Skills & Competencies
Excellent interpersonal and communication skills (oral and written)
Ability to negotiate, influence, and represent Bayer at internal and external meetings
Strong analytical skills to assess complex/ambiguous situations and predict future regulatory trends
Multi-tasking and project management skills under time pressure without compromising quality or compliance
Solid knowledge of compliance aspects related to regulatory affairs and national health authority processes
Global regulatory understanding (EU, US, ICH, GCP, GMP) is highly desired
Additional Information
Bayer is an equal opportunity employer committed to fairness and respect in the workplace
Applications are welcome from individuals regardless of race, religion, gender, age, disability, sexual orientation, or other characteristics
Contact Information
Phone: +91 22-25311234
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