Rusan Pharma, a globally recognized research-driven pharmaceutical company, is hiring for the position of Regulatory Affairs (API) in Mumbai. This opportunity is ideal for professionals with solid expertise in API regulatory documentation, DMF preparation, and international submissions. Join Rusan Pharma to be part of a company that values innovation, compliance, and excellence in pharmaceutical development.
Key Responsibilities
- Coordinate with CMC teams to compile and review regulatory documentation.
- Review quality-related and process-related documents.
- Interpret and apply country-specific AMV guidelines.
- Ensure regulatory documents comply with applicable global standards.
- Prepare and review the impurity section of DMFs.
- Compile DMFs in CTD format and submit in eCTD format.
- Handle queries raised by regulatory authorities.
- Manage DMF revisions, renewals, and annual updates.
Qualifications
- Graduate or Postgraduate in Pharmacy or a related discipline.
- Minimum 5 years of experience in Regulatory Affairs (API).
- Strong understanding of DMF preparation, CTD/eCTD submissions, and global API regulations.
- Excellent documentation, coordination, and communication skills.
Benefits
- Competitive salary package (₹6–8 LPA).
- Group Mediclaim and Accident Insurance coverage.
- Weekly off on alternate Saturdays and all Sundays.
- In-house meal facility and supportive work environment.
- Global exposure to niche regulatory projects.
About Rusan Pharma
Rusan Pharma is a leading research-driven pharmaceutical company with manufacturing units in India and a global footprint across formulations, APIs, and intermediates. Headquartered in Kandivali (West), Mumbai, Rusan Pharma operates advanced facilities in Ankleshwar, Dehradun, and Kandla SEZ, approved by Health Canada, EUGMP, and EDQM.
How to Apply
Interested candidates can apply by sending their resume to:
📧 namrata.mishra@rusanpharma.com
FAQs
1. What is the required experience for this role?
Applicants should have at least 5 years of experience in Regulatory Affairs (API), preferably with DMF preparation and CTD/eCTD submission knowledge.
2. Where is the job location?
This role is based in Mumbai, covering areas like Vasai, Bandra, Kandivali, Goregaon, Andheri, and Malad.
