Everest Clinical Research · 1 day ago
Associate Director, Regulatory Strategy and Submissions
United States
Full-time
Remote
Lead/Staff, Director/Executive
$160K/yr - $200K/yr
8+ years expEverest Clinical Research is a full-service contract research organization providing a broad range of expertise-based clinical research services. The Associate Director, Regulatory Strategy and Submissions will lead the development and execution of global regulatory strategies and participate in health authority interactions for client programs.
Pharmaceutical
Responsibilities
Lead the development and execution of regulatory strategies for assigned projects
Research and interpret relevant global regulations, guidance documents, and precedents to inform strategy
Provide strategic regulatory and scientific input for clinical development plans, clinical trial design and protocol development, product development and lifecycle planning
Identify potential regulatory risks and propose mitigation solutions
Direct the preparation, review, and finalization of regulatory submissions, working closely with internal teams and clients
Author and review regulatory submission documents, including INDs, CTAs, NDAs, BLAs, MAAs, amendments, briefing packages, scientific advice documents, requests for expedited pathways, and other regulatory filings
Ensure submissions are scientifically sound, consistent, and compliant with global regulatory requirements
Support and lead health authority interactions, including development of questions, meeting requests and briefing packages, meeting rehearsals, meeting attendance, and meeting minutes
Support clients and Everest senior staff in presenting to FDA, EMA, MHRA, Health Canada, and other agencies
Depending on project needs, serve as regulatory agency point of contact on behalf of clients
Work closely with project management, clinical operations, pharmacovigilance, biometrics, medical writing, medical affairs, quality, and business development colleagues to integrate regulatory input and ensure regulatory strategy is aligned with overall project goals and timelines
Provide oversight of medical writing staff involved in the authorship of regulatory, scientific, and clinical documents for submission to regulatory authorities in support of clinical trials, marketing applications, and other regulatory submissions
Serve as a regulatory point of contact for assigned projects, and participate in client meetings to provide regulatory advice and guidance
Monitor evolving regulatory guidelines and industry trends; summarize key developments for Everest project teams and clients, and assess impact on ongoing and future projects
Contribute to internal knowledge sharing and training
Contribute to development of marketing materials for Everest regulatory strategy and submissions services, including white papers, blog posts, etc
As a regulatory subject matter expert, participate in budget and proposal development, client presentations, bid defense meetings, and other business development activities as requested
Qualification
Required
Advanced degree (PhD) in life sciences, pharmacy, or related discipline
Minimum of 8 years of regulatory affairs experience in the pharmaceutical, biotech, or CRO industry
Experience preparing and contributing to global regulatory submissions for early- and late-stage development programs
Experience interacting with regulatory authorities (FDA, EMA, MHRA, Health Canada, etc.)
Strong knowledge of ICH guidelines and eCTD submission requirements, standards, and tools
Ability to manage multiple concurrent projects, including both strategic and hands-on responsibilities
Preferred
RAC Certification Preferred But Not Required
Experience in multiple therapeutic areas preferred; oncology, CNS, and rare diseases desirable
Company
Everest Clinical Research
Everest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$0.1MKey Investors
FedDev
2020-12-07Acquired
2019-08-18Grant· $0.1M
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