SRG is seeking an Associate Director, Regulatory Affairs for a client in Gaithersburg, MD.
This position can be 100% remote and is with a major pharmaceutical company. Candidates should have 4-6+ years of related experience in the biopharma industry.
- Contribute to regulatory submission strategy, identifying submission risks and opportunities, and leading complex regulatory applications and managing procedures through to approval
- Providing regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverables
- Submission delivery strategy of all dossiers and all application types per market and/or region
- Review of documents (e.g. response documents, study protocols, PSRs, etc.)
- Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product
- Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s lifecycle from either a global and/or regional perspective
- Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant
- BS in a Scientific field or advanced degree (MS, PharmD, PhD, etc.)
- Significant regulatory experience within the biopharmaceutical industry
- Skills and experience in dealing with health authorities
- Experience with both clinical trial applications as well as marketing applications; INDs, NDAs, BLAs, etc.
- Project management skills, and the ability to lead cross-functional teams while working on complex submissions
- Oncology therapeutic area is a plus but not required
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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