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

4 years

0 Lacs

Posted:1 month ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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. Show more Show less

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