Associate Director, Regulatory Affairs & Submissions Nonclinical Development

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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 youre a recent college graduate or seeking your next career opportunity its time to discover your future at Altasciences.

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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 Youll 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 Youll Need to Succeed

• PhD (preferred) or MSc in Pharmacology Toxicology Pharmaceutical Sciences or related discipline or an equivalent combination of relevant experience and education.

• 810 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 &TelehealthPrograms

Altasciences Incentive Programs Include:

• Training & Development Programs

• Employee Referral BonusProgram

• Annual Performance Review

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract develop and retain highly talented employees from diverse backgrounds allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age race color religion creed sex sexual orientation gender identity national origin disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!