"Rusan Pharma Hiring Regulatory Affairs (API) in Mumbai | Pharma Jobs 2025"

"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:

📧 Email: namrata.mishra@rusanpharma.com
Subject: Application for Regulatory Affairs (API) – Mumbai

🔗 You may also apply via the official company job link (if available).

❓ FAQs:-

Q1. Experience required?
👉 Minimum 5 years in API regulatory affairs with DMF exposure.

Q2. Job location?
👉 Mumbai (Kandivali / nearby western suburbs).

Q3. Who should apply?
👉 Professionals experienced in global regulatory submissions (API).

Share on WhatsApp

Explore Related Pharma Opportunities & Insights:

• ▶ Medtronic – Senior Microbiologist (Sterilisation Supervisor) | Italy Opportunity

  Lead sterility assurance and microbiology teams at Medtronic’s Mirandola site — role includes audits, CAPA, and process improvements.

• ▶ Wipro – Medical Device Complaint Investigator | Walk-in Interview Kolkata

  Freshers welcome: investigate medical device complaints, support RCA and regulatory reporting — walk-in on 29 Oct 2025.

• ▶ Top 10 Pharma Companies in India 2025–26 | Best Firms for Pharma Careers

  Discover leading pharma employers, career outlook, and where to find the best job opportunities for pharmacy graduates.

Stay updated with Pharma Duniya for verified job alerts, industry analysis, and career resources. Join our WhatsApp channel for daily posts.