Associate Director, Regulatory Affairs – Submissions, Nonclinical Development

Altasciences

Associate Director, Regulatory Affairs guiding nonclinical drug development at Altasciences. Collaborating with teams to translate data into regulatory strategies and supporting early-phase drug development.

Posted 7/29/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in nonclinical regulatory strategies, including IND/CTA submissions and compliance with global regulatory frameworks. Proficient in medical writing and risk assessment, with a strong focus on mentoring and collaboration across multidisciplinary teams.

Highest-signal resume keywords

PhD Or MSc In Pharmacology, Toxicology, Pharmaceutical Sciences8–10+ Years Of Regulatory Affairs ExperienceExpertise In Nonclinical Components Of IND/CTA SubmissionsStrong Understanding Of Global Regulatory FrameworksExperience In Medical Writing And Preparation Of Nonclinical Regulatory Dossiers

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Nonclinical Regulatory Strategy DevelopmentIND/CTA Submission PreparationToxicology AssessmentPharmacology AssessmentRisk AssessmentData InterpretationRegulatory ComplianceSOP DevelopmentGLP, GMP, GCP KnowledgeProject Management

Soft Skills

Analytical SkillsProblem-Solving SkillsStrong Communication SkillsMentoring SkillsCollaboration Skills

Industry Keywords

FDAEMAHealth CanadaICH GuidelinesNonclinical DevelopmentDrug DevelopmentBiologicsGene TherapiesSmall MoleculesTherapeutic Areas

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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