DMF Specialist Job at OrciMed Lifesciences for US FDA Type II DMF, eCTD, IND, NDA, ANDA regulatory submissions.
About the Company
OrciMed Lifesciences is a fast-growing pharmaceutical and life sciences organization specializing in regulatory affairs, drug development support, and technical documentation for global markets. The company works closely with pharmaceutical manufacturers, API producers, and regulated market clients to ensure compliance with international regulatory standards, particularly those of the US FDA. DMF Specialist Job at OrciMed Lifesciences
OrciMed Lifesciences is known for its strong technical expertise in Drug Master Files (DMFs), eCTD submissions, and lifecycle management of regulatory dossiers. The organization fosters a professional and compliance-driven culture, offering regulatory professionals an opportunity to work on complex, high-value submissions in a globally regulated environment. DMF Specialist Job at OrciMed Lifesciences
Job Details
- Job Title: DMF Specialist
- Company Name: OrciMed Lifesciences
- Job Type: Full-Time
- Industry: Pharmaceuticals / Regulatory Affairs
- Job Location: Hyderabad, India
- Work Mode: Onsite / Hybrid (as per company policy)
- Application Mode: Email Application
- Job Status: Verified Job
Job Description
OrciMed Lifesciences is currently hiring an experienced DMF Specialist to strengthen its Regulatory Affairs team. This role is ideal for professionals with hands-on expertise in Type II Drug Master File submissions, US FDA regulatory filings, and eCTD documentation. DMF Specialist Job at OrciMed Lifesciences
The DMF Specialist will play a critical role in preparing, managing, and maintaining high-quality regulatory dossiers related to APIs, manufacturing processes, and control strategies. This position offers exposure to complex regulatory submissions, confidential technical documentation, and direct interaction with cross-functional teams supporting global regulatory compliance. DMF Specialist Job at OrciMed Lifesciences
Candidates with strong experience in IND, NDA, and ANDA submissions and a deep understanding of US FDA expectations will find this role both challenging and rewarding.
Key Responsibilities
As a DMF Specialist at OrciMed Lifesciences, the selected candidate will be responsible for the following activities:
- Preparation, compilation, and submission of Type II Drug Master Files (DMFs) to the US FDA
- Authoring and reviewing detailed technical sections of DMFs, including:
- Manufacturing process descriptions
- Validation and qualification reports
- Specifications, analytical methods, and control strategies
- Managing the complete DMF lifecycle, including:
- Initial submissions
- Amendments and updates
- Annual reports
- Responses to regulatory agency queries and deficiency letters
- Supporting IND, NDA, and ANDA submissions in compliance with US FDA regulatory requirements
- Preparing and maintaining regulatory dossiers in electronic Common Technical Document (eCTD) format
- Coordinating with internal teams such as Analytical Development, Manufacturing, Quality Assurance, and Quality Control to gather accurate technical data
- Documenting specialized analytical techniques, testing methodologies, and process controls
- Preparing detailed descriptions of manufacturing facilities, including sterile processing facilities where applicable
- Ensuring regulatory documents meet current US FDA guidelines, data integrity standards, and submission timelines
- Maintaining confidentiality of proprietary technical and regulatory information
DMF Specialist Job at OrciMed Lifesciences
Skills / Qualifications
Educational Qualifications
- Bachelor’s degree in Pharmacy
- Master’s degree in Pharmacy
- Degree in Life Sciences or a related scientific discipline
Experience & Technical Expertise
- Proven hands-on experience with Type II DMF submissions
- Strong working knowledge of US FDA regulatory requirements
- Experience supporting IND, NDA, and ANDA regulatory submissions
- Practical exposure to preparing and managing eCTD submissions
- Understanding of API manufacturing processes, validation, and control strategies
Professional Skills
- Excellent regulatory and technical writing skills
- Strong attention to detail and document accuracy
- Ability to manage multiple submissions and regulatory timelines
- Capability to handle confidential and proprietary technical documentation
- Effective communication and cross-functional collaboration skills
DMF Specialist Job at OrciMed Lifesciences
Salary & Compensation
- Estimated Salary Range: ₹6,00,000 to ₹10,00,000 per annum
- Salary will be based on experience, regulatory expertise, and interview performance
- Competitive compensation aligned with pharmaceutical industry standards
DMF Specialist Job at OrciMed Lifesciences
Benefits / Perks
- Opportunity to work on global US FDA regulatory submissions
- Exposure to complex and high-value DMF projects
- Professional growth in a specialized regulatory affairs role
- Collaborative work environment with experienced regulatory professionals
- Long-term career development in regulatory documentation and compliance
- Stable employment in a growing pharmaceutical organization
Why You Should Join
Joining OrciMed Lifesciences as a DMF Specialist provides an excellent opportunity to build deep expertise in Drug Master File preparation and US FDA regulatory submissions. The role allows professionals to work on technically challenging dossiers and gain valuable exposure to global regulatory standards. DMF Specialist Job at OrciMed Lifesciences
Employees benefit from a structured regulatory environment, access to experienced mentors, and opportunities to grow within a specialized domain of regulatory affairs. This position is ideal for professionals seeking long-term career advancement in DMF management, eCTD submissions, and international regulatory compliance. DMF Specialist Job at OrciMed Lifesciences
FAQs
Who can apply for the DMF Specialist role?
Candidates with a Bachelor’s or Master’s degree in Pharmacy or Life Sciences and hands-on experience with Type II DMF submissions can apply.
Is US FDA experience mandatory?
Yes. Strong experience with US FDA regulatory submissions, including DMFs and eCTD, is required.
Does this role involve eCTD submissions?
Yes. The role includes preparation and management of regulatory dossiers in eCTD format.
Is this an onsite or hybrid role?
The work mode will be onsite or hybrid, depending on company policy and project requirements.
What regulatory submissions will I work on?
You will work on Type II DMFs and support IND, NDA, and ANDA submissions.
How to Apply
Interested and qualified candidates should share their updated CV via email:
Email ID: careers@orcimedlifescienecs.com
Please mention “DMF Specialist Application” in the email subject line to ensure faster processing of your application.
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