Job Title: Regulatory Affairs Manager – ADC
Location: Mumbai, India
Work Mode: On-site
Experience Required: Minimum 7 years
Salary: Not specified
Job Summary:
Join a global leader in healthcare innovation as a Regulatory Affairs Manager – ADC based in Mumbai. This specialist role is ideal for professionals with in-depth regulatory expertise in drug and biologic development, particularly Antibody Drug Conjugates (ADC). You'll manage complex product submissions, collaborate with regulatory bodies, and guide lifecycle compliance and approvals across India and global markets.
Key Responsibilities:
Lead preparation and submission of product registration dossiers, supplements, and progress reports.
Serve as the regulatory expert for ADC-related products throughout the product lifecycle.
Communicate with regulatory authorities to expedite approvals of pending applications.
Participate in product planning, CMC documentation, and regulatory risk management.
Ensure regulatory compliance for new drugs, biologics, and medical devices.
Advise internal stakeholders on manufacturing changes, technical labeling, and relevant regulations.
Support regulatory strategy development and implementation across functional teams.
Represent regulatory affairs in meetings with R&D, marketing, and external authorities.
Required Skills & Qualifications:
Associate Degree or higher in Life Sciences, Pharmacy, or a related discipline.
Minimum of 7 years’ experience in regulatory affairs within the pharmaceutical or biotech sector.
Comprehensive knowledge of global and Indian regulatory requirements including CDSCO.
Hands-on experience in regulatory submissions, CMC, and lifecycle management.
Familiarity with ADCs, biologics, or oncology products preferred.
Strong communication, documentation, and project management skills.
Perks & Benefits:
Opportunity to lead strategic regulatory initiatives for ADC and biologic products.
Exposure to global regulatory environments and health authority interactions.
Collaborate with multidisciplinary teams on breakthrough therapies.
Professional growth in a high-impact, innovation-driven pharma setting.
Company Description:
We are a global healthcare company dedicated to pioneering advanced therapies and driving access to life-changing treatments. Our regulatory affairs division ensures compliant, strategic product development and approvals across India and international markets.
Work Mode:
On-site – Mumbai, India
Call to Action:
Ready to make a regulatory impact in cutting-edge ADC therapies? Apply now to shape the future of pharmaceutical compliance and patient access.
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