Are you passionate about regulatory affairs and ensuring compliance with US FDA standards? OrciMed Life Sciences, a leading pharmaceutical company, is hiring a DMF Specialist in Hyderabad to join our dynamic team. This role offers an exciting opportunity to contribute to the preparation and maintenance of Drug Master Files (DMFs) for NDA, ANDA, and IND submissions, ensuring compliance with FDA regulations. If you have expertise in eCTD submissions and a strong understanding of 21 CFR requirements, apply today to advance your career in pharmaceutical regulatory affairs!
Responsibilities
As a DMF Specialist at OrciMed Life Sciences, you will:
- Prepare, submit, and maintain Drug Master Files (DMFs) in compliance with US FDA regulations and guidance.
- Ensure adherence to 21 CFR requirements for all DMF submissions.
- Manage eCTD submissions through the FDA Gateway, ensuring accuracy and timeliness.
- Collaborate with cross-functional teams to support NDA, ANDA, and IND submissions.
- Communicate effectively with the FDA to address queries and ensure compliance.
- Utilize back-end coding skills to streamline DMF processes and documentation.
- Stay updated on FDA regulations, guidance, and industry best practices for regulatory affairs.
Qualifications
To excel in this role, you should have:
- A degree in B.Pharm, M.Pharm, Pharm.D, MSc, BSc, or Life Sciences.
- Strong knowledge of US FDA regulations, particularly 21 CFR requirements.
- Experience with eCTD submissions and FDA Gateway processes.
- Familiarity with back-end coding for regulatory documentation (preferred).
- Excellent communication skills for FDA interactions and team collaboration.
- Detail-oriented with strong organizational and time-management skills.
- 2+ years of experience in regulatory affairs or DMF preparation (preferred).
Benefits
Joining OrciMed Life Sciences offers:
- Competitive salary in the range of INR 6,00,000 – 10,00,000 per annum.
- Opportunities for professional growth in pharmaceutical regulatory affairs.
- Collaborative and innovative work environment in Hyderabad.
- Comprehensive health and wellness benefits.
- Access to continuous learning and development programs.
How to Apply
Ready to make an impact in pharmaceutical regulatory affairs? Send your resume and a cover letter to careers@orcimedlifesciences.com with the subject line “DMF Specialist Application – [Your Name]”. Applications are reviewed on a rolling basis, so apply by October 27, 2025, to be considered.
FAQs
Q: What is the role of a DMF Specialist at OrciMed Life Sciences?
A: The DMF Specialist prepares and maintains Drug Master Files, ensures FDA compliance, and supports eCTD submissions for NDA, ANDA, and IND applications.
Q: What qualifications are required for the DMF Specialist role?
A: Candidates need a B.Pharm, M.Pharm, Pharm.D, MSc, BSc, or Life Sciences degree, with knowledge of 21 CFR requirements and eCTD submissions.
