Associate Director, Regulatory Affairs & Submissions - Nonclinical Development

Original job posting

The Associate Director provides strategic regulatory guidance for nonclinical development programs, ensuring scientific rigor and compliance for IND, CTA, and NDA/BLA submissions. They lead cross-functional teams and serve as a subject matter expert during health authority interactions to facilitate efficient drug development.

Job details

About 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. What You’ll Need to Succeed * 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 administration. * Strong understanding of global regulatory frameworks governing nonclinical development (FDA, EMA, ICH M3, ICH S guidelines). * Proven track record of interpreting nonclinical data to inform regulatory strategy and risk assessment in various therapeutic areas, including but not limited to Endocrinology and Metabolism, CNS, Cognitive, Movement and Neuromuscular disorders, Ophthalmology. * Experience in medical writing and preparation of nonclinical regulatory dossiers. * Solid knowledge of GLP, GMP, and GCP requirements as applicable to the nonclinical development stage. * Excellent analytical, problem-solving, and project management skills. * Strong communication skills, with the ability to articulate complex scientific information to diverse stakeholders. * Leadership experience, including mentoring or managing regulatory or scientific staff. Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Associate Director, Regulatory Affairs – Nonclinical Development including, but not limited to, for the following reasons: * The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies. * The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices. * The employee frequently communicates with English-only customers outside the province of Quebec. What We Offer: Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work. Altasciences' Benefits Package Includes: * Health/Dental/Vision Insurance Plans * 401(k)/RRSP with Employer Match * Paid Vacation and Holidays * Paid Sick and Bereavement Leave * Employee Assistance & Telehealth Programs Altasciences' Incentive Programs Include: * Training & Development Programs * Employee Referral Bonus Program * Annual Performance Review #LI-AN1

What you’ll do

The Associate Director provides strategic regulatory guidance for nonclinical development programs, ensuring scientific rigor and compliance for IND, CTA, and NDA/BLA submissions. They lead cross-functional teams and serve as a subject matter expert during health authority interactions to facilitate efficient drug development.

Requirements

Candidates must possess a PhD or MSc in a relevant scientific discipline with 8–10+ years of regulatory experience focused on nonclinical drug development. Strong expertise in global regulatory frameworks, medical writing, and the ability to interpret complex nonclinical data are essential for success in this role.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401(k)
• RRSP
• Employer match
• Paid vacation
• Paid holidays
• Paid sick leave
• Bereavement leave
• Employee assistance program
• Telehealth programs
• Training and development programs
• Employee referral bonus program

Listed skills

• Leadership · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory affairs
• Nonclinical drug development
• Pharmacology
• Toxicology
• ADME
• IND/CTA submissions
• Regulatory strategy
• Gap analysis
• Medical writing
• Project management
• Risk assessment
• GLP compliance
• GMP compliance
• GCP compliance
• Leadership
• Mentoring
• Regulatory Affairs
• Good Laboratory Practice (GLP)
• Small Molecules
• Regulatory Frameworks
• Neuromuscular System And Disorders
• Proposal Strategy
• Biopharmaceuticals
• Business Development
• Biologics License Applications (BLA)
• Good Manufacturing Practices
• Metabolism
• Customer Service
• Clinical Research
• Clinical Trials
• Communication
• Regulatory Compliance
• Training And Development
• Cumulative Translation Adjustment (CTA)
• Drug Development
• Employee Assistance Programs
• Endocrinology
• English Language
• French Language
• Information Sciences
• Problem Solving
• Legislation
• Project Management
• Medical Writing
• Mentorship
• Non-Disclosure Agreement (Intellectual Property Law)
• Ophthalmology
• Performance Review
• Pharmaceutical Sciences
• Regulatory Requirements

Job areas

• Healthcare
• Science & Research
• Management & Leadership
• Consulting
• Associate Director of Regulatory Affairs
• Clinical Director
• Health Service Managers
• Medical and Health Services Managers