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"Rusan Pharma Hiring Regulatory Affairs (API) in Mumbai | Pharma Jobs 2025"
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"Rusan Pharma Hiring for Regulatory Affairs (API) in Mumbai | Apply Now"
(Pharma Regulatory Jobs 2025 – Mumbai)
(Rusan Pharma Hiring Regulatory Affairs (API) in Mumbai)
Rusan Pharma, a globally recognised and research-driven pharmaceutical organisation, has announced a job opening for Regulatory Affairs (API) at its Mumbai location. This opportunity is ideal for experienced regulatory professionals with strong expertise in DMF preparation, CTD/eCTD submissions, and global API regulations.
If you are passionate about regulatory compliance and want to work with an internationally approved pharmaceutical company, this role offers excellent career growth and global exposure.
About Rusan Pharma:-
Rusan Pharma is a trusted name in the pharmaceutical industry, known for innovation, compliance, and quality-driven manufacturing.
The company specialises in API, formulations, and intermediates and operates globally approved facilities at:
Ankleshwar
Dehradun
Kandla SEZ
✅ Approved by EUGMP, EDQM, Health Canada, and other global regulators.
✅ Head Office: Kandivali (West), Mumbai.
Key Responsibilities – Regulatory Affairs (API):-
Coordinate with CMC teams to compile regulatory documentation
Review quality & process documents for regulatory accuracy
Interpret and apply country-specific AMV regulatory guidelines
Prepare & review impurity sections of DMFs
Compile Drug Master Files (DMF) in CTD format
Submit regulatory dossiers in eCTD format
Handle DMF renewals, revisions, and annual updates
Respond to queries from global regulatory authorities
Ensure compliance with international regulatory standards
Required Qualifications:-
✅ Education
B.Pharm or M.Pharm (or equivalent discipline)
✅ Experience
Minimum 5 years in Regulatory Affairs (API)
Strong experience in DMF, CTD & eCTD submissions
✅ Skills
Global API regulatory knowledge (US, EU preferred)
Strong regulatory writing & documentation skills
Excellent coordination & communication abilities
Employee Benefits:-
✔ Salary: ₹6 – ₹8 LPA (based on experience)
✔ Group Mediclaim & Accident Insurance
✔ Free in-house meal facility
✔ Global regulatory exposure
✔ Weekly off: All Sundays + Alternate Saturdays
✔ Supportive & professional work environment
How to Apply:-
Interested and eligible candidates can apply via email:
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