"OrciMed Life Sciences Hiring DMF Specialist in Hyderabad – Apply Now"
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| (OrciMed Pharma) |
Are you looking to grow your career in pharmaceutical regulatory affairs? OrciMed Life Sciences, a reputed and rapidly expanding pharma company, is inviting applications for the role of DMF Specialist in Hyderabad. This position is an excellent opportunity for candidates with expertise in Drug Master Files (DMFs), US FDA compliance, and eCTD submissions to join a professional and innovation-driven team.
About the Role: DMF Specialist:-
As a DMF Specialist at OrciMed Life Sciences, you will play a key role in ensuring that the company’s regulatory submissions comply with FDA regulations and 21 CFR requirements. You will be responsible for preparing and maintaining DMFs while collaborating with cross-functional teams for NDA, ANDA, and IND submissions.
Key Responsibilities:-
- Prepare, submit, and maintain Drug Master Files (DMFs) in compliance with US FDA guidelines.
- Ensure adherence to 21 CFR requirements for all regulatory filings.
- Manage eCTD submissions via the FDA Gateway with precision and timeliness.
- Support NDA, ANDA, and IND submissions through effective coordination.
- Communicate with the FDA to resolve queries and maintain compliance.
- Leverage back-end coding skills (if applicable) to streamline documentation.
- Stay updated with evolving FDA regulations and industry best practices.
Required Qualifications:-
- Degree in B.Pharm, M.Pharm, Pharm.D, MSc, BSc, or Life Sciences.
- Strong understanding of US FDA guidelines and 21 CFR regulations.
- Hands-on experience with eCTD submissions and FDA Gateway processes.
- Knowledge of back-end coding for regulatory workflows (preferred).
- Excellent communication and documentation skills.
- 2+ years of experience in regulatory affairs or DMF preparation (preferred).
Benefits of Joining OrciMed Life Sciences:-
- Competitive annual package: INR 6,00,000 – 10,00,000.
- Career growth in regulatory affairs and FDA compliance.
- Collaborative and supportive work culture.
- Comprehensive healthcare and wellness benefits.
- Learning and development opportunities to enhance skills.
How to Apply:-
Interested candidates can apply by sending their updated CV and cover letter to:
📧 careers@orcimedlifesciences.com
with the subject line: “DMF Specialist Application – [Your Name]”.
Last Date to Apply: October 27, 2025
FAQs:-
Q1: What does a DMF Specialist do at OrciMed Life Sciences?
A: The role involves preparing and maintaining Drug Master Files, managing eCTD submissions, and ensuring compliance with US FDA regulations.
Q2: What qualifications are needed for this role?
A: Candidates must hold a pharma or life sciences degree with knowledge of 21 CFR requirements and regulatory submissions.
This opportunity is perfect for professionals aiming to advance in regulatory affairs and pharmaceutical compliance with a globally trusted organization.
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