Rusan Pharma Hiring for Regulatory Affairs API role in Mumbai. Apply now for ₹6–8 LPA pharma career opportunity.
Rusan Pharma Recruitment 2025 – Regulatory Affairs (API) Jobs in Mumbai
Rusan Pharma, a globally recognized and research-driven pharmaceutical company, is inviting applications for the Regulatory Affairs (API) position at its Mumbai office. This is an excellent opportunity for experienced professionals in the pharmaceutical regulatory domain to join a reputed company known for its innovation, compliance, and excellence in API and formulation development. Rusan Pharma Hiring for Regulatory Affairs
Founded with a commitment to improving patient outcomes and ensuring product quality, Rusan Pharma has established itself as a trusted name in the pharmaceutical industry with global operations across multiple markets. Rusan Pharma Hiring for Regulatory Affairs
Job Overview
- Position: Regulatory Affairs (API)
- Company: Rusan Pharma Ltd.
- Location: Mumbai (Vasai, Bandra, Kandivali, Goregaon, Andheri, Malad)
- Qualification: B.Sc, B.Pharm, M.Sc, or M.Pharm
- Experience: 4 – 7 Years
- Salary: ₹6 – ₹8 LPA (Approx.)
- Job Type: Full-time, On-site
- Application Mode: Email
Key Responsibilities
- Coordinate with CMC teams to compile, review, and finalize regulatory documentation.
- Review and interpret quality-related and process-related documents in compliance with global standards.
- Apply and interpret country-specific AMV guidelines for different regulatory submissions.
- Ensure all regulatory documentation aligns with international regulatory requirements.
- Prepare and review the impurity section of Drug Master Files (DMFs).
- Compile DMFs in CTD format and handle submissions in eCTD format.
- Manage and respond to regulatory authority queries efficiently and accurately.
- Oversee DMF revisions, renewals, and annual updates.
Required Qualifications and Skills
- Bachelor’s or Master’s degree in Pharmacy, Science, or a related discipline.
- Minimum 5 years of experience in Regulatory Affairs (API).
- In-depth knowledge of DMF preparation, CTD/eCTD submissions, and global API regulations.
- Excellent analytical, documentation, and communication skills.
- Strong attention to detail and ability to manage multiple projects simultaneously.
- Rusan Pharma Hiring for Regulatory Affairs
Benefits of Working at Rusan Pharma
- Competitive salary structure (₹6–8 LPA).
- Group Mediclaim and Accident Insurance coverage for employees.
- Weekly off on alternate Saturdays and all Sundays.
- Access to an in-house meal facility and a supportive work culture.
- Opportunity to work on international regulatory projects and gain global exposure.
About Rusan Pharma
Rusan Pharma is a leading research-driven pharmaceutical company with a strong presence in formulations, APIs, and intermediates. Headquartered in Kandivali (West), Mumbai, the company operates world-class manufacturing units located in Ankleshwar, Dehradun, and Kandla SEZ. Rusan Pharma Hiring for Regulatory Affairs
These facilities are approved by global regulatory authorities such as Health Canada, EUGMP, and EDQM, reflecting Rusan’s unwavering commitment to quality and compliance. The company continues to expand its footprint across international markets with a focus on innovative healthcare solutions. Rusan Pharma Hiring for Regulatory Affairs
How to Apply
Interested candidates can apply by sending their updated resume to the HR department at the email address below: Rusan Pharma Hiring for Regulatory Affairs
Email: namrata.mishra@rusanpharma.com
FAQs
1. What is the required experience for this role?
Candidates should have a minimum of 5 years of experience in Regulatory Affairs (API), particularly in DMF preparation and CTD/eCTD submissions.
2. Where is the job located?
This position is based in Mumbai, covering areas such as Vasai, Bandra, Kandivali, Goregaon, Andheri, and Malad.
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