Executive / AM - Regulatory Affairs

Executive / AM - Regulatory Affairs

1 Nos.
111499
Full Time
5.0 Year(s) To 10.0 Year(s)
4.00 LPA TO 8.00 LPA
Production / Quality / Maintenance
B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry; M.Sc / MS Science - Organic Chemistry
Job Description:

 Key Responsibilities:

    • Prepare, compile, and review regulatory submissions (CTD/eCTD formats) for product registrations, renewals, and variations as per regional and international guidelines.
    • Ensure timely submission and follow-up of applications with regulatory authorities.
    • Maintain up-to-date knowledge of changes in drug regulatory environments and communicate impacts to relevant departments.
    • Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Supply Chain) to gather necessary documentation.
    • Maintain regulatory documentation, databases, and records in compliance with internal procedures and regulatory standards.
    • Assist in handling product labelling, artwork approvals, and packaging compliance.
    • Respond to regulatory queries and deficiencies from health authorities in a timely manner.
Key Skills :
Company Profile

Job Description: Export Assistant/Officer – ---ceutical Industry - Vadodara Location

Position: Export Assistant / Officer

Candidate Profile:

Education: Graduate (Bachelor’s degree in Commerce, Business, International Trade, or a related field).


Experience: Minimum 1+ years of experience in a ---ceutical company (export department preferred).

 

CTC Range : up to 3,50,000-/-

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