Director, Regulatory Medical Writing
Remote | Oncology | NDA Submissions | FDA-Facing Leadership
A growing oncology-focused biopharmaceutical organization is seeking an experienced Director of Regulatory Medical Writing to support late-stage regulatory submission activities for its endometrial cancer program. This is a highly visible, strategic role with the opportunity to evolve into a submission lead position for a critical oncology asset.
The ideal candidate will possess a strong blend of deep clinical foundational knowledge, advanced regulatory writing expertise, and meaningful experience interacting directly with the FDA. This individual will initially partner closely with Regulatory Affairs leadership and will have the opportunity to become the lead writer on the program once they demonstrate strong clinical understanding and effectiveness in regulatory and FDA-facing activities.
Key Responsibilities
- Lead the planning, development, and authoring of regulatory submission documents in support of NDA filings
- Drive preparation and ownership of key Module 2 documents and summaries
- Support regulatory strategy and document integration for oncology programs
- Collaborate cross-functionally with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, and related teams
- Participate in FDA interactions, regulatory responses, and submission-related communications
- Ensure all documents are scientifically accurate, strategically aligned, and compliant with FDA and ICH requirements
- Mentor and provide guidance to junior medical writers and CSR-focused writing teams
- Contribute to regulatory writing process improvements and best practices
Qualifications
- Advanced scientific degree required (PhD, PharmD, MD, or equivalent)
- Significant regulatory medical writing experience within biotech, pharma, or CRO environments
- Oncology experience required
- Strong hands-on experience authoring and leading NDA submissions, particularly Module 2 documentation
- Deep clinical foundational experience required
- Demonstrated experience with heavy FDA interaction, including submission support, regulatory communications, and agency-facing activities
- Ability to independently manage complex writing projects and timelines in a fast-paced environment
- Excellent communication, collaboration, and leadership skills
Preferred Experience
- Experience mentoring or overseeing junior writers or vendors
- Familiarity with oncology indications
- Proven ability to operate strategically within cross-functional regulatory teams
Additional Information
- Fully remote opportunity
- Primarily focused on US regulatory submissions
- European submission experience is not required
- Open to candidates from CRO environments
- Opportunity to grow into a lead regulatory writing role with increased submission ownership and FDA visibility
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
