Associate Director, Regulatory Affairs & Submissions - Nonclinical Development
Altasciences
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Benefits offered by this job
Job summary
Altasciences is seeking an Associate Director, Regulatory Affairs – Nonclinical Development to lead regulatory strategy for nonclinical programs. You will guide preclinical submissions, align cross‑functional teams, and ensure high-quality scientific documentation for IND/CTA and other regulatory filings.
The role requires 8–10+ years in regulatory affairs with a focus on nonclinical development, strong medical writing skills, and leadership experience to mentor junior staff.
Qualifications
- PhD or MSc in pharmacology, toxicology, pharmaceutical sciences, or related field.
- Nonclinical regulatory experience in IND/CTA submissions and GLP/GMP/GCP familiarity.
- Experience with small molecules, biologics, or gene therapies.
- Strong regulatory writing and cross-functional collaboration skills.
- Leadership experience mentoring regulatory or scientific staff.
Responsibilities
- Provide strategic regulatory guidance for nonclinical development programs.
- Develop and execute nonclinical regulatory strategies for early drug development.
- Lead preparation and review of nonclinical sections of regulatory submissions (IND/CTA/NDA/BLA).
- Interpret global regulatory requirements (FDA/EMA/Health Canada/ICH) for nonclinical safety.
- Act as SME during health authority interactions and meetings.
- Collaborate with crossfunctional teams to align development strategies.
- Translate data into regulatory narratives and submission-ready docs.
- Support business development with regulatory input and client consultations.
- Contribute to SOPs and best practices in nonclinical regulatory science.
Skills
Education
Job description
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 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.
- 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 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.
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Review
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!
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 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.
- 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 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.
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Review
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!
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