CMC Regulatory Expert (United States)

Overview

We are looking for an independent chemistry manufacturing and controls (CMC) consultant with expertise in project management of Module 3 section authoring in connection with the preparation of biologics and synthetic drug regulatory applications for submission to FDA and other regulatory regions.

More specifically, the independent consultant (1099 vs W2) would work as a subcontractor with our clients on behalf of Regulatory Interlinx, Inc. The work would include Module 3 (CMC section) authoring and project management for FDA (NDAs), EU (MAAs) and rest-of-world submissions for approval of new biologics and synthetic drugs. The work could also involve the authoring of CMC sections of briefing books, investigator brochures, marketing applications, clinical trial applications, post approval submissions and responses to health authority questions.

Qualifications include drug development experience in biologics and synthetic organic chemistry and/or formulation development of synthetic drugs. Candidates will have strong dossier writing experience and be able to manage challenging timelines. In addition, candidates should be reasonably technically savvy enough to help with GenAI prompt engineering to support dossier section template creation using a new GenAI platform.

Specifics

The candidate will represent the department on multi-functional project development teams to support regulatory filings and has expertise in new drug development and authoring Module 3 CMC regulatory applications. The candidate is responsible, with limited guidance from the company manager [MM1] , for developing the technical Module 3 eCTD sections to support Regulatory CMC dossier applications. With limited guidance from the manager, the candidate will author CMC regulatory submissions, coordinate authoring, review and approval of these documents, and providing technical oversight [SF2] for the generation of the Module 3 CMC dossier for marketing and clinical trial submissions. The candidate will coordinate the timeline and the generation of the Quality module and will assume ownership and accountability for business results and solutions working with limited supervision from the manager. 

Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with limited guidance from the manager. The candidate drafts and supports [SF3] the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications with limited guidance from the manager. The candidate will evaluate and ensure the completeness, accuracy and compliance of data provided for regulatory submissions with limited guidance from the manager and the candidate will ensure Quality submissions are completed in a timely manner. 

Job Scope/Span of Influence

1. Contributes to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level

2. Communicates and executes dossier strategy/product development plan with high level of autonomy and accountability

3. Provide feedback on expected program resources required based on conversations with the CMC Team.

4. Executes, leads and/or supervises [SF4] dossier authoring activities for early and late-stage projects with limited or no guidance from manager 

5. Participate in continuous improvement activities relating to Dossier Templates and DDO Best Practices.' With limited or no guidance, interfaces directly with CMC/Tech team members, Regulatory, supply chain stakeholders, external service providers

6. Interfaces with internal and external functional stakeholders

7. Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance and occasionally at multiple levels of management

8. Combines technical expertise with management skills.

9. Manages several complex projects with potentially accelerated priority OR

leads complex Phase 3 clinical programs

10. Challenges status quo and identifies innovative approaches to improve products/processes

11. Independently resolves isolated cross-functional issues

12. Appropriately identifies and manages key stakeholders and escalates when needed to obtain senior management support. With limited guidance, takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly

13. Works independently on a day-to-day basis, checks in with supervisor as needed for identified high-priority issues

Education & Experience

Experience with innovator product submissions (non generics)

PhD with Post-doc experience with 6+ years relevant experience

OR University degree with 8+ years relevant experience

OR Equivalent by experience