Our client in Cambridge, MA is seeking a Sr Manager with experience working with QC Documentation, specifically in regards to Regulatory Documentation.
- Lead documentation preparation for regulatory submissions (CMC sections for BLA/MAA/NDA, briefing books, responses to questions from Health Authorities). Responsible for delivery of high quality submission-ready documentation.
- Serve as a technical writing and editing expert to team members and manage continuous process improvements. Ensure submission's compliance with regulatory requirements and internal quality standards.
- Lead analytical/QC activities during the technology transfer and qualification of new manufacturing sites. Review and approve validation documentation; assure high quality of generated results and data integrity.
- Partner with GRA CMC, Tech Operations and Supply Operations groups to ensure high quality and timely delivery of submission ready documentation.
- Lead preparation of CMC sections in CTD format for new submissions and post-approval changes.
- Lead compilation of responses to questions from Health Authorities. Provide technical expertise for CMC-related questions.
- Review validation documentation, study protocols and reports to maintain compliance and assure high quality of generated data.
- Oversee testing for process validation activities at multiple CROs, as applicable.
- Assure collaborative, proactive, and effective communication with internal teams and external vendors and partners.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelors Degree in any Life Sciences and 10+ years of relevant experience or Master's Degree in any Life Sciences with relevant laboratory coursework and 8+ years of relevant experience.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Good knowledge and familiarity with technical writing requirements.
- Understanding of CMC regulatory requirements across major markets.
- Experience with small molecule and biologic products.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment.
- Excellent written, oral and presentation communication skills in English.
Sthree US is acting as an Employment Business in relation to this vacancy.