Associate Director, Regulatory Affairs – Submissions, Nonclinical Development

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🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Altasciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2017-06

Healthcare • Consulting • Logistics

Altasciences is a forward-thinking, mid-size early phase contract research organization located in Canada and the U. S. , catering to biopharmaceutical companies of all sizes. The company specializes in offering a flexible approach to early drug development, with services that include preclinical safety testing, clinical pharmacology from Phase I to Phase II, bioanalysis from preclinical to Phase IV, as well as research and manufacturing analytical services. Altasciences is committed to accelerating early-phase drug development, ensuring seamless transitions from lead candidate selection to proof of concept and beyond, thereby delivering impactful results with a personal touch.

📋 Description

• 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

• 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

• 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