We’re seeking a highly experienced and strategic Senior Regulatory Affairs Manager to join our team in Nehru Place, Delhi.
This is a key leadership role for a seasoned regulatory professional with 10+ years of experience in the pharmaceutical or life sciences industry. You will oversee all regulatory strategies, submissions, and compliance activities to ensure our products meet national and international standards.
The ideal candidate is a decisive leader with a proven track record in managing successful regulatory submissions and product approvals, both in India and global markets.
Develop and implement comprehensive regulatory strategies for product development and commercialization.
Lead the preparation, submission, and maintenance of regulatory dossiers, licenses, and registrations.
Serve as the primary liaison with regulatory authorities such as CDSCO and other national/international bodies.
Monitor and interpret changes in regulatory guidelines and laws, ensuring timely communication to stakeholders.
Manage and mentor a team of Regulatory Affairs professionals, fostering continuous improvement and compliance culture.
Conduct internal audits and inspections to ensure adherence to regulatory standards.
Collaborate cross-functionally with R&D, QA, and Marketing teams to integrate compliance into all product lifecycle stages.
Identify regulatory risks and develop proactive mitigation strategies.
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
Minimum 10 years of progressive experience in Regulatory Affairs.
Demonstrated success in managing complex regulatory submissions and obtaining product approvals in India and international markets.
In-depth understanding of CDSCO guidelines, ICH, GMP, and other regulatory frameworks.
Strong leadership, analytical, and problem-solving skills.
Excellent written and verbal communication abilities.
This is an exceptional opportunity to:
Play a strategic leadership role in a high-performing regulatory team.
Influence key organizational decisions in product approvals and compliance.
Work in a dynamic, growth-focused environment with continuous learning opportunities.
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