Associate Director, Regulatory Strategy and Submissions

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. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Associate Director, Regulatory Strategy and Submissions for our Toronto (Markham), Ontario on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Position Summary

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. This role will work cross-functionally with Everest project management, medical writing, clinical, medical, safety, biometrics, quality, and business development teams to deliver regulatory strategy and submissions services that meet client goals and global health authority expectations.

Responsibilities Include:

1. Regulatory Strategy Support
   • 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.
2. Regulatory Submissions Planning and Oversight
   • 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.
3. Health Authority Interactions
   • 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.
4. Cross-functional Collaboration
   • 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
5. Regulatory Intelligence & Best Practices
   • 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.
6. Marketing and Business Development
   • 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.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at  

Estimated Salary Range: $160,000 - $200,000.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

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