OrciMed Lifesciences is currently hiring an experienced DMF Specialist to strengthen its regulatory affairs team. This opportunity is ideal for regulatory professionals with hands-on expertise in Type II DMF submissions, US FDA regulatory filings, and eCTD documentation. Candidates with strong exposure to IND, NDA, and ANDA submissions and technical regulatory content will find this role highly rewarding.
This role offers an excellent platform to work on complex regulatory dossiers, proprietary technical documentation, and global compliance activities in a fast-growing pharmaceutical organization.
Key Responsibilities – DMF Specialist
As a DMF Specialist at OrciMed Lifesciences, your responsibilities will include:
- Preparation, compilation, and submission of Type II Drug Master Files (DMFs)
- Authoring and reviewing technical content, including:
- Validation reports
- Manufacturing process details
- Specifications and control strategies
- Managing DMF lifecycle activities, including amendments, annual updates, and responses to agency queries
- Supporting IND, NDA, and ANDA submissions as per US FDA requirements
- Preparing and maintaining dossiers in eCTD format
- Coordinating with internal teams for analytical, manufacturing, and quality data
- Documenting specialized analytical techniques and testing methods
- Providing detailed descriptions of manufacturing facilities, including sterile processing facilities where applicable
Required Qualifications & Skills
To be successful in this DMF Specialist role, candidates should have:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline
- Proven hands-on experience with Type II DMF submissions
- Strong working knowledge of IND, NDA, and ANDA regulatory pathways
- Experience in preparing and managing eCTD submissions
- Solid understanding of US FDA regulatory guidelines
- Ability to handle confidential and proprietary technical documentation
- Excellent written communication and regulatory writing skills
Why Join OrciMed Lifesciences?
- Opportunity to work on global regulatory submissions
- Exposure to complex DMF and US FDA filings
- Professional growth in a specialized regulatory affairs role
- Collaborative work environment with regulatory and technical experts
- Competitive compensation aligned with industry standards
Salary Range
💰 Estimated Salary: ₹6,00,000 – ₹10,00,000 per annum (INR)
(Salary may vary based on experience, expertise, and interview performance.)
Job Location
📍 Location: India (Onsite / Hybrid – as per company policy)
How to Apply
Interested and qualified candidates should share their updated CV to the email address below:
📧 careers@orcimedlifescienecs.com
Mention “DMF Specialist Application” in the email subject line for faster processing.
