$120K — $150K
Job description: Senior Manager Regulatory CMC
We are seeking an experienced Associate Director Regulatory CMC to support CMC functions and to manage and draft CMC-related content for global regulatory filings for both clinical and commercial. This role will liaise with other functions, provide input into regulatory expectations for CMC activities, manage submission deliverables, draft needed regulatory content, and collaborate with internal and external cross-functional teams.
Description: Supports preparation of submission content, including sections of CTD Module 3. Critically review documents for consistency and quality, identifying gaps in CMC supporting documentation, and make technical edits, as necessary.
Develop authoring plans and strategic approaches to the generation of submission content for both clinical and commercial applications, including IDE/IND/CTAs, PMA/NDA/MAAs, briefing documents, DMFs and/or post-approval changes.
Independently authoring CMC sections, as well as guiding the authoring and review of CMC content by relevant technical experts (internal and external).
Extracts and summarizes scientific information from development reports and identify details required for regulatory submissions.
Actively collaborates with internal and external stakeholders, including Pharmaceutical and Device Development, Quality, CROs, CMOs, and consultants
Provide technical functions clear, concise guidance on current CMC regulatory requirements to support company goals. Provide expert recommendations and decisions on regulatory issues relating to CMC, including submission risk and mitigation due to CMC matters.
Ensure that the regulatory records in internal documentation systems are accurate and complete. Will contribute to development of new internal processes and SOPs as necessary.
Minimum Requirements –Education and Experience
Skills and Capabilities
MUST be within driving distance to office. Currently a remote position. NO sponsorship for this permanent position.
Valid through: 4/21/2021
$100K — $150K
5 days ago