The Scientist/Technical Writer, is responsible for managing and preparing the entire drug substance and drug product analytical sections of regulatory submissions in the clinical space and entire dossier in the commercial space.
This role requires effective collaboration across technical functions to deliver on timelines for submissions. The candidate is expected to have a thorough understanding of regulatory guidelines. The position routinely interfaces with experts in Process Development, Manufacturing Sciences and Technology, Operations, Analytical Science and Technology, Quality and Regulatory Sciences. The successful candidate will work effectively in cross functional project teams and also independently to accomplish company goals
Job Responsibilities include:
Independently author CMC elements of regulatory filings.
Carries out integrated review process for documents and leads the finalization of drafts for next phase review.
Develop, improve and implement templates for CMC filings.
Develop authoring plans and strategic approaches to filings with Biologics Development (Process and Analytical Sciences).
Plan the authoring and review of CMC Regulatory documents.
Functional representation in collaboration with GRS CMC teams and BD technical experts, creates final drafts of Regulatory documents for submission to GRS and onwards to global Health Authorities.
Must possess the ability to support multiple projects and to prioritize work independently.
Author regional filings and amendments for approved products.
Documents included: BLA, MAA, IND, IMPD, Briefing packs, PAS, CBE-0, CBE-30, Variations, etc.
Critically review documents for consistency and quality.
Promote standardization of submission process within organization.
Works independently and collaborates with other groups.
Delivers results in line with project and team objectives.
B.S. with 5+ years or M.S. with 3+ years in the pharmaceutical industry with experience in Biotech product development and manufacturing, advanced degree preferred.
Experience in preparation of regulatory documentation
Strong Analytical background
Knowledge of biotech drug regulations essential (ICH and other governing documents US and global)
Excellent verbal and written communication skills
The ability to handle multiple tasks independently and manage competing priorities.
Excellent collaboration skills with focus on timely delivery
Strong organization and analytical skills
Project management skills and experience required