Associate Director, Regulatory Affairs & Submissions - Nonclinical Development
Listed on 2026-08-01
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Research/Development
Clinical Research -
Healthcare
Clinical Research
Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well‑being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team!
Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well‑being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team!
Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.
The Role
The Associate Director, Regulatory Affairs – Nonclinical Development is a strategic regulatory leader specializing in nonclinical drug development. This role is responsible for guiding regulatory strategy for preclinical programs, ensuring that nonclinical data packages (pharmacology, toxicology, and ADME) are positioned to support successful clinical entry and market application submissions.
The Associate Director partners closely with sponsors and cross‑functional teams to translate complex nonclinical data into clear regulatory strategies, enabling efficient progression of small molecules, biologics, and advanced therapeutic products into the clinic.
What You’ll Do Here- Provide strategic regulatory guidance focused on nonclinical development programs, including pharmacology, toxicology, and IND/CTA‑enabling studies.
- Develop and execute nonclinical regulatory strategies to support early‑phase drug development and clinical trial applications.
- Lead the preparation and critical review of nonclinical sections of regulatory submissions (IND, CTA, NDA/BLA), ensuring scientific rigor and regulatory compliance.
- Conduct gap analyses of nonclinical data packages, identifying risks and defining mitigation strategies for regulatory success Interpret and apply global regulatory requirements (FDA, EMA, Health Canada, ICH,) related to nonclinical safety and pharmacology.
- Serve as a subject matter expert during health authority interactions, including briefing documents and meeting support (e.g., INTERACT, pre‑IND, scientific advice).
- Collaborate with Nonclinical, Clinical, Toxicology, Pharmacology, DMPK, and Medical Writing teams to ensure aligned development strategies.
- Translate complex scientific data into clear regulatory narratives and submission‑ready documentation, leveraging strong medical writing expertise.
- Support business development activities, including proposal strategy, regulatory input, and client consultations.
- Contribute to and implement SOPs and best practices related to nonclinical regulatory science and submissions
- Mentor and guide junior regulatory professionals, fostering scientific and regulatory excellence.
- PhD (preferred) or MSc in Pharmacology, Toxicology, Pharmaceutical Sciences, or related discipline or an equivalent combination of relevant experience and education.
- 8–10+ years of Regulatory Affairs experience with a strong focus on nonclinical drug development.
- Demonstrated expertise in nonclinical components of IND/CTA submissions, including toxicology, pharmacology, and safety assessment.
- Experience supporting a range of modalities (e.g., small molecules, biologics, gene therapies) and routes of…
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