Job Description
RRxCo is partnered exclusively with a clinical-stage Biotechnology Company that develops novel medicines for severe immune disorders. Focused on the field of auto-immune disorders, our client is set to develop several assets over the coming years.
Summary
The individual will be a highly motivated and experienced Associate Director, CMC Technical Writer, to join a dynamic and growing team. The ideal candidate will have a proven track record in regulatory strategy and operational execution.
As the Associate Director, CMC Technical Writer you will report directly to the VP Head of CMC and will be instrumental in driving our CMC activities, ensuring compliance with global regulations, and contributing to the successful development and commercialization of innovative therapies.
You will collaborate closely with cross-functional teams, including CMC, Regulatory, and Quality to advance our pipeline and bring life-changing treatments to patients.
Essential Functions
1. Author, review, and manage high-quality, compliant CMC source and regulatory documents (including IND Module 3 sections and IMPDs) for use in Regulatory submissions.
2. The position will be focused on CMC and will need a good understanding of CMC lifecycle maintenance activities across EU and ROW markets.
3. Work collaboratively with RA colleagues and SMEs to interpret and summarize complex data.
4. Prepare and coordinate the review and approval of submission-ready documents.
5. Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
6. Perform regulatory assessment of CMC changes, identify global regulatory requirements, and evaluate supporting documentation to assess acceptability and identify potential risks.
7. Provide interpretation of regulatory guidance documents, regulations, and directives and advise CMC regarding their applicability and impact on internal programs.
8. Perform technical review of certificate of analysis, analytical test methods, specifications, product development reports, Master Batch Records (MBR), validation protocol/report, and stability protocol/report/data.
9. Represent CMC on regulatory activities in cross-functional project teams and maintain collaborative partnerships with stakeholders.
Education
1. Bachelor's degree in a scientific discipline.
2. 8+ years of experience in CMC, minimum of 5 years of experience with biologics.
3. Experience with monoclonal antibodies & biologic-device combination products strongly preferred.
4. Strong knowledge of current Global CMC regulations, including CTD format and content of CMC regulatory submissions.
5. Demonstrated experience authoring CMC sections in Module 3 sections and IMPD of regulatory filings required.
6. Ability to read, analyze and interpret technical documents and health authority regulations.
7. Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones.
8. Exceptional written and oral communication skills.
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