Job Overview:
We’re seeking a highly experienced and strategic Senior Regulatory Affairs Manager to join our team in Nehru Place, Delhi. This is a critical leadership role for a seasoned professional with a minimum of 10 years of experience in the regulatory domain. You will be responsible for leading all regulatory strategies and activities to ensure our products comply with national and international standards. The ideal candidate will be a decisive leader with a proven track record of successful regulatory submissions and approvals.
Key Responsibilities:
- Develop and implement comprehensive regulatory strategies to support product development and commercialization.
- Lead the preparation, submission, and maintenance of regulatory dossiers, licenses, and registrations for various products.
- Serve as the primary liaison with regulatory authorities like CDSCO and other relevant bodies.
- Stay up-to-date on changes in regulatory guidelines, laws, and industry standards, and effectively communicate their impact to internal stakeholders.
- Manage a team of regulatory affairs professionals, providing mentorship and guidance.
- Conduct internal audits and inspections to ensure continuous compliance with all regulatory requirements.
- Collaborate with cross-functional teams (R&D, Quality Assurance, Marketing) to ensure regulatory requirements are integrated into all stages of the product lifecycle.
- Manage regulatory risks and develop mitigation plans.
Qualifications & Experience:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 10 years of progressive experience in Regulatory Affairs.
- Proven expertise in managing complex regulatory submissions and obtaining product approvals in India and international markets.
- In-depth knowledge of regulatory frameworks (e.g., CDSCO guidelines, ICH, GMP).
- Strong leadership, analytical, and problem-solving skills.
- Excellent written and verbal communication skills.
Salary:
💰 We offer a competitive package of up to ₹25 Lacs per annum, commensurate with experience and expertise.
Location:
📍 Nehru Place, Delhi
Why Join Us?
This is an opportunity to take on a senior leadership role, influence strategic decisions, and work in a dynamic and challenging environment with a high-performing team.
To apply for the job, please fill the form: https://forms.gle/y6x7tgEeN37Dxcsu6