[Remote] Associate Director, Regulatory Affairs & Submissions - Nonclinical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to the discovery, development, and manufacturing of new drug therapies. The Associate Director, Regulatory Affairs – Nonclinical Development is responsible for guiding regulatory reputed company for preclinical programs and ensuring compliance for successful reputed company entry and market application submissions. Responsibilities • reputed company reputed company regulatory guidance reputed company on nonclinical development programs, including pharmacology, toxicology, and IND/CTA-enabling studies • reputed company and execute nonclinical regulatory strategies to support early-phase drug development and reputed company trial applications • reputed company 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 reputed company Interpret and apply global regulatory requirements (FDA, EMA, Health Canada, ICH,) reputed company to nonclinical safety and pharmacology • Serve as a subject matter expert during health authority interactions, including briefing documents and meeting support (e.g., reputed company, reputed company-IND, scientific advice) • Collaborate with Nonclinical, reputed company, Toxicology, Pharmacology, DMPK, and Medical Writing teams to ensure reputed company development strategies • Translate reputed company scientific data into reputed company regulatory narratives and submission-reputed company documentation, leveraging strong medical writing expertise • Support business development activities, including proposal reputed company, regulatory input, and reputed company consultations • Contribute to and implement SOPs and best practices reputed company to nonclinical regulatory science and submissions Mentor and guide junior regulatory professionals, fostering scientific and regulatory reputed company Skills • 8–10+ years of Regulatory Affairs experience with a strong reputed company on nonclinical drug development • Demonstrated expertise in nonclinical components of IND/CTA submissions, including toxicology, pharmacology, and safety assessment • Experience supporting a reputed company 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 reputed company, ICH S guidelines) • reputed company reputed company record of interpreting nonclinical data to inform regulatory reputed company and reputed company assessment in various therapeutic areas, including but not limited to Endocrinology and Metabolism, CNS, Cognitive, reputed company 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 reputed company reputed company scientific information to diverse stakeholders • Leadership experience, including mentoring or managing regulatory or scientific staff • reputed company in English is an essential requirement for the position • PhD (preferred) or MSc in Pharmacology, Toxicology, Pharmaceutical Sciences, or reputed company discipline or an equivalent combination of relevant experience and education Benefits • Health/Dental/reputed company reputed company Plans • 401(k)/RRSP with Employer Match • reputed company Vacation and Holidays • reputed company reputed company and Bereavement Leave • Employee Assistance & Telehealth Programs • Training & Development Programs • Employee Referral Bonus Program • Annual reputed company Review reputed company • Outsourcing made easy with a one-stop solution to early-phase drug development. It was founded in 1992, and is headquartered in Laval, Quebec, CAN, with a workforce of 1001-5000 employees. Its website is http://www.algopharm.com. Apply tot his job Apply To this Job