Altasciences
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About Altasciences At Altasciences, we accelerate the discovery, development, and manufacturing of new drug therapies. Our collaborative culture values employee development, customer focus, quality, respect, integrity, and excellence. We seek talented, enthusiastic people ready to make a global health impact.
Role Overview The Senior Director, Regulatory Affairs leads regulatory strategy and compliance for early‑stage first‑in‑human and first‑in‑class molecules. This role ensures alignment with business goals and regulatory requirements, manages a regulatory team, and serves as the primary liaison with global health authorities (FDA, EMA, Health Canada).
What You’ll Do
Partner with business development to engage potential clients at the discovery phase.
Consult with clients pre‑award to delineate regulatory requirements.
Define, prepare, and present regulatory strategy plans.
Create, present, and defend content for proposals.
Build, mentor, and manage a high‑performing regulatory team.
Serve as the point of contact for regulatory questions and oversee interactions with regulatory agencies.
Collaborate with Clinical, CDMO, Nonclinical, Medical Writing, and Project Management teams to integrate regulatory planning and execution.
Lead preparation for pre‑IND (Investigational New Drug) and pre‑CTA (Clinical Trial Application) meetings.
Oversee regulatory submission requirements and provide content for submissions.
Implement SOPs and best practices to enhance efficiency and compliance.
Monitor new regulatory requirements or guidance documents and advise on impact.
Identify overall regulatory risks in partnership with project teams and participate in mitigation strategies.
Qualifications
PhD in a related discipline preferred; 10+ years of regulatory affairs experience in a CRO, biopharma, or biotech setting.
Proven success leading early‑stage regulatory strategy and submissions in North America (FDA, Health Canada) across multiple indications.
Deep knowledge of FDA and Health Canada frameworks, including CTA and IND processes.
Excellent scientific and business judgment with strong risk assessment skills.
Understanding of GMP, GLP, and GCP.
Exceptional verbal and written communication.
Professional attitude, strong interpersonal skills, and ability to work cross‑disciplinary.
Benefits Pay range $150,000–$200,000 per year, commensurate with experience. Altasciences offers a comprehensive benefits package including health/dental/vision insurance, 401(k) with employer match, paid vacation, paid sick and bereavement leave, employee assistance and telehealth programs, and telework when applicable.
Equal Opportunity Altasciences is an equal‑opportunity employer committed to diversity and inclusion. All qualified applicants receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or any protected ground. Reasonable accommodations for persons with disabilities are available upon request.
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About Altasciences At Altasciences, we accelerate the discovery, development, and manufacturing of new drug therapies. Our collaborative culture values employee development, customer focus, quality, respect, integrity, and excellence. We seek talented, enthusiastic people ready to make a global health impact.
Role Overview The Senior Director, Regulatory Affairs leads regulatory strategy and compliance for early‑stage first‑in‑human and first‑in‑class molecules. This role ensures alignment with business goals and regulatory requirements, manages a regulatory team, and serves as the primary liaison with global health authorities (FDA, EMA, Health Canada).
What You’ll Do
Partner with business development to engage potential clients at the discovery phase.
Consult with clients pre‑award to delineate regulatory requirements.
Define, prepare, and present regulatory strategy plans.
Create, present, and defend content for proposals.
Build, mentor, and manage a high‑performing regulatory team.
Serve as the point of contact for regulatory questions and oversee interactions with regulatory agencies.
Collaborate with Clinical, CDMO, Nonclinical, Medical Writing, and Project Management teams to integrate regulatory planning and execution.
Lead preparation for pre‑IND (Investigational New Drug) and pre‑CTA (Clinical Trial Application) meetings.
Oversee regulatory submission requirements and provide content for submissions.
Implement SOPs and best practices to enhance efficiency and compliance.
Monitor new regulatory requirements or guidance documents and advise on impact.
Identify overall regulatory risks in partnership with project teams and participate in mitigation strategies.
Qualifications
PhD in a related discipline preferred; 10+ years of regulatory affairs experience in a CRO, biopharma, or biotech setting.
Proven success leading early‑stage regulatory strategy and submissions in North America (FDA, Health Canada) across multiple indications.
Deep knowledge of FDA and Health Canada frameworks, including CTA and IND processes.
Excellent scientific and business judgment with strong risk assessment skills.
Understanding of GMP, GLP, and GCP.
Exceptional verbal and written communication.
Professional attitude, strong interpersonal skills, and ability to work cross‑disciplinary.
Benefits Pay range $150,000–$200,000 per year, commensurate with experience. Altasciences offers a comprehensive benefits package including health/dental/vision insurance, 401(k) with employer match, paid vacation, paid sick and bereavement leave, employee assistance and telehealth programs, and telework when applicable.
Equal Opportunity Altasciences is an equal‑opportunity employer committed to diversity and inclusion. All qualified applicants receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or any protected ground. Reasonable accommodations for persons with disabilities are available upon request.
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