Are you passionate about pharmaceutical compliance and regulatory submissions?
DDReg Pharma, a leading regulatory consulting and life sciences company, is hiring for the position of Associate – Regulatory Affairs (India Market) at its Gurgaon office. This is an exciting opportunity for professionals with hands-on experience in CDSCO regulations, SUGAM Portal submissions, and product lifecycle management for drugs, cosmetics, medical devices, and nutraceuticals.
If you’re ready to advance your career in regulatory affairs and contribute to India’s evolving healthcare landscape, this role is tailor-made for you.
🧾 Key Responsibilities
As an Associate – Regulatory Affairs, you will:
- Manage CDSCO submissions for new drugs, generics, biologicals, medical devices, nutraceuticals, and cosmetics.
- Prepare and review registration dossiers and import license applications.
- Handle SUGAM Portal submissions and maintain compliance documentation.
- Manage product lifecycle activities, including renewals and amendments.
- Liaise with CDSCO/DCGI for approvals and deficiency resolution.
- Obtain and maintain key licenses (CT, COS, MD, Form 41, etc.).
- Submit applications to FSSAI and Legal Metrology for nutraceutical approvals.
- Stay updated on regulatory intelligence and implement change management processes.
- Ensure compliance with GMP and quality management systems (QMS).
🎓 Educational Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
- Minimum 3+ years of experience in regulatory affairs for drugs, cosmetics, nutraceuticals, and medical devices.
- Proficiency in CDSCO regulations, SUGAM Portal, and dossier preparation.
- Strong understanding of regulatory frameworks for imports, new drug approvals, and registration processes.
- Excellent communication, analytical, and time-management skills.
💼 Benefits & Career Growth
- Opportunity to work with a leading regulatory consulting firm.
- Exposure to multi-category product portfolios (Drugs, Devices, Nutraceuticals).
- Collaborative and innovation-driven environment.
- Professional growth and regulatory training opportunities.
📝 How to Apply
