Assistant Manager / Manager/ Senior Manager - Regulatory Affairs (ROW/SRA Markets)

We’re Hiring: Assistant Manager / Manager/ Senior Manager - Regulatory Affairs (ROW/SRA Markets)

Location: Andheri West, Mumbai

Experience: 4 to 8 years

Qualification: B.Pharm / M. Pharm (Mandatory)

Salary: As per Industry

Joining: 30 days to 60 days

Open Positions: (6)

Omnicals Pharma Pvt. Ltd., a trusted and growing name in the pharmaceutical industry, is seeking experienced professionals to join our Regulatory Affairs team. We encourage you to apply. If you have a strong background in regulatory submissions of finished formulations and are looking for a new opportunity with Global Pharma Company with aggressive regulatory filings in order to own 3000+ Marketing Authorization /IP’s/Brands in more than 40+ Countries by 2029.

Key Responsibilities:

* Preparation and submission of dossiers for ROW, PIC/S, EU markets in ICH CTD, ACTD, and EUCTD 

 formats.

* Overseeing the registration process of pharmaceutical products in international markets.

* Managing regulatory correspondence with consultants and Ministries of Health with overseas travel .

* Ensuring compliance with ICH guidelines and relevant regulatory standards.

* Responding to queries and deficiencies from regulatory authorities in a timely and effective manner.

Candidate Profile:

* Experience with top 10 Finished formulation/ Pharmaceutical Companies in the industry.

* Strong command of English with excellent written and verbal communication skills.

* Consistent career progression with minimal job changes.

* Sound knowledge of regulatory norms and submission requirements across Global Markets.

How to Apply:

Interested candidates can share the updated CV at nidhi@omnicals.com or apply directly on Linkedin.

We look forward to welcoming talented regulatory professionals who are committed to excellence and growth & business travels to overseas markets.