We are Hiring!!!

Job Title: Drug Regulatory Affairs Executive
Department: Regulatory Affairs
Location: Kala Amb, Himachal Pradesh
Experience: 2 to 5 years

Role Overview:

We are looking for a motivated, detail-oriented Drug Regulatory Affairs Executive to join our Regulatory Affairs team. You will prepare, review, compile and submit regulatory dossiers for pharmaceutical products in regulated and semi-regulated markets.

Key Responsibilities:

Prepare and compile CTD and ACTD dossiers for regulatory submissions.
Prepare and review Module 1 to Module 5 documents as per country-specific regulatory requirements.
Review regulatory documents, including COAs, specifications, artworks, PILs, labels and packaging materials.
Handle product registration activities and respond to queries from clients and health authorities within timelines.
Coordinate with internal departments (R&D;, QA, QC, Production and Packaging) to collect the required documents and data.




Coordinate with third-party vendors and consultants for regulatory documentation support.
Maintain submission trackers, registration status records and regulatory databases.
Ensure compliance with applicable regulatory guidelines and company standards.

Qualifications:

B.Pharmacy or M.Pharmacy
Candidates must be from a pharmaceutical background only, with prior experience in regulatory affairs in a pharma company.

Required Skills:

Working knowledge of CTD/ACTD formats and regulatory guidelines for regulated and semi-regulated markets.
Strong documentation, review and attention-to-detail skills.
Positive written and verbal communication, and the ability to coordinate across teams. Ability to manage multiple submissions and meet deadlines.

How to Apply Interested candidates can send their resume to [email protected]

Pay: ₹25,000.00 - ₹30,000.00 per month

Work Location: In person

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