Senior Manager (Level 1), Regulatory Affairs CMC in Noida, भारत

Senior Manager role in regulatory affairs focused on chemistry, manufacturing, and controls (CMC) for medicinal products, medical devices, and related categories. Responsibilities include client relationship management, regulatory documentation preparation, project oversight, and team leadership across human and veterinary product portfolios.

Responsibilities

• Develop and maintain client relationships; drive service opportunities and identify cross-selling prospects
• Prepare, review, and compile CMC regulatory documentation for product applications, renewals, and variations
• Lead project teams to deliver within budget; coordinate with internal and external partners
• Represent clients in communications with health authorities and scientific advice procedures
• Mentor colleagues on CMC services; maintain and share regulatory intelligence across organization

Requirements

• Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health, or related field
• 10+ years experience in scientific consulting, healthcare, or life sciences sector
• 2+ years in management capacity
• Demonstrated ability to lead and mentor staff; strong project management skills
• Advanced written and verbal communication in English; local language proficiency preferred
• Strategic planning capability and client relationship management at senior level
• Certification in regulatory affairs, clinical research, or health economics preferred