[Hiring] Associate Director, Regulatory Strategy and Submissions @Everest Clinical Research

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As a member of the Global Regulatory Strategy and Submissions team, the Associate Director, Regulatory Strategy and Submissions, will lead the development and execution of global regulatory strategies, author and review high-quality submissions, and participate in health authority interactions for client programs in drug, biologic, combination product, and medical device development.

• 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.

Qualifications

• Advanced degree (PhD) in life sciences, pharmacy, or related discipline.
• RAC certification preferred but not required.
• 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.).
• Experience in multiple therapeutic areas preferred; oncology, CNS, and rare diseases desirable.
• 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.

Requirements

• None specified.

Benefits

• None specified.

Company Description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. Apply tot his job Apply To this Job