Deputy Director, Regulatory Affairs and Submissions - Non-Clinical Development

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At Altasciences, we all work together to contribute to the discovery, development, and manufacturing of new medicinal therapies so they can reach people who need them faster. 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 around the world. By upholding our values of employee development, customer orientation, quality and excellence, respect, and integrity, we seek 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 are a recent university graduate or looking for your next career opportunity, it is time to discover your future at Altasciences.

We are better together and that is how we are Altasciences.

About the role

The Deputy Director, Regulatory Affairs and Submissions - Non-Clinical Development is a strategic leader in regulation, specializing in the non-clinical development of medicines. This role involves guiding the regulatory strategy for preclinical programs, ensuring that non-clinical data files (pharmacology, toxicology, and ADME) are sufficiently robust to support the successful transition to the clinical phase and market authorization applications.

The Deputy Director, Regulatory Affairs and Submissions - Non-Clinical Development works closely with clients and interdisciplinary teams to translate complex non-clinical data into clear regulatory strategies, enabling efficient progression to the clinical phase of small molecules, biologic products, and advanced therapeutic products.

What you will do here

• Provide strategic regulatory advice focused on non-clinical drug development programs, including pharmacology, toxicology, and IND/CTA preparation studies.
• Develop and implement non-clinical regulatory strategies to support early drug development and clinical trial applications.
• Lead the preparation and critical review of non-clinical sections of regulatory files (IND, CTA, NDA/BLA), ensuring scientific rigor and regulatory compliance.
• Conduct gap analyses in non-clinical data files, identifying risks and defining mitigation strategies to ensure regulatory success. Interpret and apply global regulatory requirements (FDA, EMA, Health Canada, ICH) related to non-clinical safety and pharmacology.
• Serve as an expert in interactions with health authorities, such as through information documents and support during meetings (e.g., INTERACT, pre-IND, scientific advice).
• Collaborate with non-clinical, clinical, toxicology, pharmacology, DMPK, and medical writing teams to ensure the consistency of development strategies.
• Translate complex scientific data into clear regulatory descriptions and submission-ready documentation, based on strong medical writing expertise.
• Support business development activities, including proposal strategy, regulatory contributions, and client consultations.
• Contribute to the development and implementation of standard operating procedures (SOPs) and best practices related to non-clinical regulatory science and submissions. Mentor and guide junior regulatory professionals, fostering scientific and regulatory excellence.

What you will need to succeed

• Doctorate (desired) or Master's degree in pharmacology, toxicology, pharmaceutical sciences, or a related discipline, or an equivalent combination of relevant experience and education.
• 8 to 10 years or more of experience in regulatory affairs, with a strong focus on the preclinical development of medicines.
• Proven expertise in the preclinical sections of market authorization application files (IND/CTA), particularly in toxicology, pharmacology, and safety assessment.
• Experience in handling a wide range of modalities (e.g., small molecules, biologic products, gene therapies) and routes of administration.
• Solid understanding of global regulatory frameworks governing preclinical development (FDA, EMA, ICH M3 and ICH S guidelines).
• Proven experience in interpreting preclinical data to support regulatory strategy and risk assessment in various therapeutic areas, including, but not limited to, endocrinology and metabolism, CNS, cognitive and motor disorders, neuromuscular disorders, and ophthalmology.
• Experience in medical writing and preparation of non-clinical regulatory files.
• Strong knowledge of GLP, GMP, and GCP requirements applicable to the non-clinical development phase.
• Excellent analytical, problem-solving, and project management skills.
• Strong communication skills, with the ability to explain complex scientific information to various stakeholders.
• Experience in leadership, such as mentoring or managing regulatory or scientific teams.

Altasciences strives to offer a French-speaking work environment to its employees in Quebec. Altasciences has taken all reasonable measures to avoid imposing the requirement to speak another language than French mentioned above. This requirement is essential for the Deputy Director, Regulatory Affairs and Submissions - Non-Clinical Development role, particularly, but not limited to, for the following reason(s):

• The obligation to have study protocols, designs, and clinical research documents written and documented in English as required by the industry's regulatory agencies.
• The employee frequently communicates with Altasciences employees across Canada and the United States. As such, English is the primary language used to correspond between offices.
• The employee frequently communicates with anglophone clients outside the province of Quebec.

What we offer

Altasciences offers a wide range of benefits designed to help our employees lead a healthy and fulfilling life, both at work and outside.

Altasciences' employee benefits program includes

• Health, dental, and vision insurance
• 401(k)/REER plan with employer contribution
• Paid time off and holidays
• Paid sick and bereavement leave
• Employee assistance and telehealth programs

Altasciences' incentive programs include

• Training and development programs
• Employee referral bonus program
• Annual performance evaluations
• #LI-AN1
• WE MOVE TOGETHER TO ACHIEVE MAXIMUM IMPACT WHILE OFFERING A PERSONAL TOUCH.

Altasciences is an equal opportunity employer committed to promoting diversity and inclusion. Our goal is to attract, develop, and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide range of experiences and perspectives. All qualified candidates will be considered for employment without regard to age, race, color, religion, belief, sex, sexual orientation, gender identity, national origin, disability, or any other protected status under applicable law. Reasonable accommodations for individuals with disabilities are available upon request. Join us at Altasciences!