Job Description:
Position: Regulatory Affairs Manager – Pharmaceuticals
Location: New Delhi, India
Department: Regulatory Affairs
Reports To: Managing Director/ Manager Operations
Role Summary:
As a Regulatory Affairs Specialist, you will play a vital role in managing the preparation and submission of high-quality regulatory documentation to health authorities to support the development, approval, and maintenance of pharmaceutical products. You will ensure that all products meet national and international regulatory requirements throughout their lifecycle.
Key Responsibilities:
- Approve labels, packaging and promotional materials (leaflets, websites, social media) for compliance under FSSR and other export market rules as per applicable guidlines.
- Summarize scientific and technical data.
- Prepare, compile, and submit regulatory dossiers for new product approvals, renewals, and variations.
- Ensure timely submissions to regulatory agencies.
- Manage communication and correspondence with health authorities.
- Track and interpret changes in pharmaceutical regulations and provide regulatory guidance to internal stakeholders.
- Review and approve product Labelling, packaging, and promotional materials for compliance with regulatory requirements.
- Support clinical trials by submitting and maintaining INDs or clinical trial applications (CTA).
- Maintain regulatory databases and documentation for inspections and audits.
- Liaise with cross-functional teams such as R&D, QA/QC, Medical Affairs, and Manufacturing to ensure compliance and regulatory readiness.
- Contribute to regulatory strategy and risk assessments during drug development and post-marketing phases.
Required Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or related field.
- 5-8 years of experience in pharmaceutical regulatory affairs.
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH, CDSCO, etc.).
- Attention to detail, critical thinking, and strong organizational skills.
- Excellent communication skills, both written and verbal.
Preferred Qualifications:
- Regulatory Affairs Certification (RAC) or equivalent is a plus.
- Familiarity with global submission platforms (e.g., ESG, CESP, EU Portal).
- Experience in new drug applications (NDA), abbreviated NDAs (ANDA), and post-marketing surveillance.
Amita Das,
Manager Operations,
+91 7065133131
Job Type: Full-time
Pay: ₹20,000.00 - ₹50,000.00 per month
Benefits:
Work Location: Remote
