Drug Master File (DMF) Specialist
Orcimed Lifesciences | Hyderabad, India
Experience Required: 3–6 years
Work Mode: Work From Office (WFO)
Location: Hyderabad
Salary Range: Competitive industry-aligned package (exact CTC based on experience)
About the Role
Orcimed Lifesciences is hiring an experienced Drug Master File (DMF) Specialist to support regulatory submissions, technical documentation, and global compliance activities. The role requires strong expertise in US FDA submissions, eCTD formatting, and technical dossier preparation. This position is ideal for candidates with hands-on regulatory experience in DMFs, IND/NDA/ANDA filings, and specialized technical content development.
Key Responsibilities
The following requirements are mandatory for this role:
Regulatory Submissions & Compliance
Proven hands-on experience in Type V DMF submissions (Pre-Approval request) to the US FDA.
Sound knowledge of IND, NDA, and ANDA regulatory pathways.
Preparation, review, and maintenance of DMFs in accordance with global regulatory expectations.
Technical Content Development
Ability to prepare and manage proprietary technical data, including:
Validation reports
Product and process specifications
Technical summaries
Manufacturing process descriptions
Expertise in authoring and reviewing technical sections associated with specialized analytical methods, testing procedures, and quality standards.
Manufacturing & Facility Documentation
Preparation of technical descriptions of manufacturing facilities, including sterile and non-sterile setups, specialized equipment, and process controls.
Adherence to global regulatory and GMP documentation guidelines.
eCTD Format Expertise
Strong experience working with eCTD submission format for DMFs and regulatory filings.
Ability to structure, publish, and validate eCTD sequences in alignment with FDA and international authority requirements.
Required Experience
3 to 6 years of relevant experience in DMF preparation, regulatory writing, or pharmaceutical submissions.
Prior experience with US FDA regulatory submissions is essential.
Hands-on exposure to Type V DMFs is mandatory.
Why Join Orcimed Lifesciences
Opportunity to work on global regulatory projects.
Exposure to advanced DMF documentation processes.
Work-from-office environment supporting collaboration and accelerated learning.
Strong growth pathway within regulatory affairs and dossier development.
How to Apply
Eligible candidates can apply through ThePharmaDaily Job Portal or directly share their updated CV with the recruitment team at Orcimed Lifesciences.
Gujarat :
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Canada |Quebec :
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Brussels |Antwerp :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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