Associate Director, Regulatory CMC

Job Description

• Lead the development of regulatory strategies and interaction with global Health Authorities; provide strategic input and regulatory advice to the project teams on clinical programs and life cycle management of marketed products • As a Regulatory CMC representative to assigned program teams, collaborate with project teams to implement Ultragenyx regulatory strategies. Ensure and/or enhance regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle. Proactively identify project CMC issues and implement appropriate regulatory strategies to mitigate risks • Manage the preparation and submission of regulatory applications (IND/CTA, NDA/BLA/MAA, annual reports, etc.) and any post-marketing commitments. Develop and/or review regulatory documents to ensure that all submissions are of high quality. Communicate with internal and external partners to obtain required supporting documents and data for compilation of regulatory submissions in a timely manner that supports agreed-upon project timelines • Coordinate the task of drafting responses to CMC related questions from FDA/global health authorities per established process • Evaluate proposed manufacturing changes for global impact to ongoing and existing dossiers and provide a regulatory assessment and a submission strategy for optimal implementation of changes • Collaborate and provide support to Regulatory International for assigned program activities in the APAC region during 2022 • Support the preparation and conduct of Agency meetings, including preparation and coordination of briefing packages • Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork

Qualifications

• BA/BS degree in life sciences in chemistry, molecular biology, or similar is required, an advanced degree is preferred. RAC certification desirable but not mandatory • 7 + years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry. Alternatively, 6 years pharmaceutical Regulatory CMC experience combined with 4+ years relevant pharmaceutical experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance or Quality Control) • Prior success filing clinical trial applications, marketing applications, amendments, supplements, and variations for drugs and/or biologics within timelines is required; global submission experience and/or knowledge of global regulations/requirements, e.g., APAC/LatAm, is a desired plus • Thorough understanding of relevant drug development regulations and guidelines is essential to support programs during development and commercial lifecycle. Proven ability to successfully interact with regulatory authorities • Working knowledge in the rare disease space and the ability to deal with issues of critical importance, providing regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance is privileged • Understanding of scientific principles and regulatory CMC requirements relevant to all stages of pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentation supported by a strong quality mindset

Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans