Regulatory Affairs Executive

4 weeks ago

Mumbai Maharashtra, India Clini launch Business Solutions Full time

We are seeking a knowledgeable and experienced Regulatory Affairs Specialist with expertise in the Drugs & Cosmetics Act and FSSAI regulations, as well as experience in FDA-related activities. This role is essential for ensuring robust functional and cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.) and for the transparent execution of regulatory affairs and safety processes.

**Key Responsibilities**:
Local Regulatory Function (Licensing):

- Prepare registration dossiers for obtaining certificates/licenses from local FDA, DCGI, and FSSAI, demonstrating thorough knowledge of the FDA, Sugam, and FSSAI online portals, as well as the Drugs & Cosmetics Act and its various schedules (e.g., Sch Y, M).
- Confirm product formula and label acceptability and ensure receipt of necessary licenses prior to product release.
- Coordinate with QC and R&D departments to gather technical documents (batch records, specifications, analytical methods, validation reports, and stability data) for incorporation into registration dossiers.
- Ensure timely renewal of drug and food licenses for both head office and branch offices across various states.
- Maintain an archive of all regulatory permissions.
- Stay updated on regulatory requirements and implement changes as needed.
- Prepare responses to legal and technical queries from regulatory authorities.

**Compliance of Packaging Modules**:

- Formulate and implement statutory requirements for product artwork (labels, cartons, package inserts, patient information leaflets, etc.).
- Review all packaging material artwork.
- Prepare package inserts in accordance with the New Drugs and Clinical Trials Rules 2019.

**Pharmacovigilance**:

- Provide high-quality medical writing, including planning and coordination of literature research.
- Draft and review Periodic Safety Update Reports (PSURs) with a focus on medical aspects and safety sections.
- Review Risk Management Plans in compliance with regulatory requirements.
- Assess the risk-benefit ratio of products and identify gaps in aggregate documents.
- Perform scientific reviews of aggregate reports and Individual Case Safety Reports (ICSRs) produced by Pharmacovigilance Associates.

**Qualifications**:

- Bachelor's or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Proven experience in regulatory affairs within the pharmaceutical or food industry.
- Strong knowledge of the Drugs & Cosmetics Act and FSSAI regulations.
- Excellent communication and organizational skills.
- Ability to work collaboratively across various departments.

**Job Types**: Full-time, Permanent

Pay: Up to ₹750,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Morning shift

Work Location: In person

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