Senior Specialist – Regulatory Affairs Manager
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Company: Merck Group
Overview:
Merck is hiring a Senior Specialist / Expert in Regulatory Affairs to support global license management, product compliance, and lifecycle strategies across therapeutic areas like Oncology, Neurology, and Fertility. This is a high-impact role in a matrixed global regulatory environment, involving the preparation of regulatory dossiers, strategic planning, and cross-functional collaboration to maintain license security and regulatory compliance.
Key Responsibilities:
Prepare regulatory dossiers for license management and ensure compliance with health authority requirements
Develop and execute regulatory strategies to support product lifecycle and market access
Conduct content and quality reviews on regulatory documentation
Interpret and apply country-specific and global regulatory guidelines
Manage regulatory risks and propose mitigation strategies in collaboration with team leads
Contribute regulatory expertise to cross-functional planning and execution of tasks
Build and maintain relationships across internal departments and external stakeholders
Utilize regulatory systems including RIM (Regulatory Information Management) and EDMS
Qualifications & Skills:
Experience: 8–12 years in pharmaceutical regulatory affairs, competent authority, or academia/R&D
Education: MSc (or higher) in Life Sciences, Pharmacy, Medicine, or related discipline; PhD preferred
Proven experience preparing and managing global regulatory documentation including full submissions and major variations
Strong knowledge of global regulatory procedures (e.g., CP, MRP, DCP, national) and lifecycle management
Hands-on experience with regulatory systems and applications (RIM, EDMS)
Project management capability and excellent documentation and communication skills
Global exposure (experience in at least two regions such as Europe, US, or International markets)
Estimated Salary: ₹25–38 LPA (based on industry averages in Bangalore for senior regulatory roles)
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