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Officer Regulatory Affairs

Regulatory Affairs Officer job in Mumbai

Looking to grow your career in Regulatory Affairs with a reputed pharmaceutical company? Encore Healthcare Pvt. Ltd., a global leader in tablet and capsule manufacturing, is hiring for the position of Officer – Regulatory Affairs at their Head Office in Fort – CSMT, Mumbai. This opportunity is perfect for candidates with 1–2 years of experience in ACTD/CTD/eCTD dossier preparation for the ROW market.

About Encore Healthcare Pvt. Ltd.

Encore Healthcare is a prominent global contract manufacturer of pharmaceutical products, with a specialization in tablet and capsule production for the Indian market. With the largest tablet manufacturing capacity in India, Encore is trusted for delivering affordable and accessible healthcare solutions.

Founded in 2002, the company operates from its manufacturing facility in Paithan, Maharashtra, offering a broad range of pharmaceutical and consumer healthcare products. Encore’s diverse portfolio includes topical, dermatological, antibiotic, anti-inflammatory, antifungal, respiratory, and nutritional products.

Officer – Regulatory Affairs: Candidate Profile

To be eligible for this role, you must meet the following criteria:

Education: B. Pharma / M. Pharma
Experience: 1–2 years in Regulatory Affairs
Location: Head Office, Fort – CSMT, Mumbai
Working Days: Monday to Friday (Weekends Off: Saturday & Sunday)
Mandatory Skill: Hands-on experience in dossier preparation (ACTD, CTD, eCTD) for ROW (Rest of the World) markets

Related Job: RA Officer/Executive at BDA Healthcare

Key Responsibilities of the Role

As an Officer – Regulatory Affairs, your day-to-day tasks will include:

  1. Preparation of regulatory dossiers in ACTD/CTD/eCTD formats for ROW markets, ensuring timely and error-free submissions.
  2. Evaluation and response to regulatory queries from authorities and clients.
  3. Review of technical documents such as process validation, AMV, stability data, and CDP from R&D/QA teams.
  4. Coordination with internal departments (Plant, QA, R&D, ADL) for documentation and samples.
  5. Artwork checking and development for product registration and commercialization.
  6. Maintaining and updating dossier records and registration statuses across regulatory platforms.

How to Apply

If you meet the above criteria and are ready to build a future in Regulatory Affairs, submit your updated resume to:

Email: rparab@encoregroup.net

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