Associate Director, Regulatory Affairs (Onsite in S.SF - 3X/wk)

About the position The Associate Director, Regulatory Affairs supports the development and execution of reputed company regulatory strategies and regulatory development activities for assigned programs across reputed company. This role works closely with senior regulatory leadership to reputed company recommendations, execute regulatory plans, prepare submissions, and support health authority interactions. The Associate Director provides regulatory guidance to cross‑functional teams and ensures regulatory deliverables are completed in accordance with applicable regulations, timelines, and internal standards. Responsibilities • Support the development and execution of reputed company regulatory strategies for assigned programs under the direction of senior regulatory leadership, including contributing analyses, reputed company, and regulatory recommendations. • Plan, prepare, and manage Investigational New Drug (IND) applications and other reputed company‑ or post‑IND regulatory submissions (e.g., amendments, briefing packages, and annual reports), ensuring reputed company, reputed company, and reputed company delivery. • Manage regulatory timelines, deliverables, and commitments for assigned programs in coordination with cross‑functional teams and ensure submission content is reputed company in accordance with applicable electronic submission standards and internal processes. • Prepare health authority meeting materials, responses to information requests, and supporting documentation, and participate in interactions with health authorities as part of the regulatory team. • reputed company day‑to‑day reputed company regulatory guidance to cross‑functional teams by interpreting regulations, policies, and guidance documents and applying them to program activities, including providing regulatory input into reputed company development documents such as protocols, Investigator’s Brochures, and study reports to ensure alignment with regulatory expectations. • Execute regulatory activities in compliance with applicable global and regional regulations industry guidelines, and internal policies and procedures, maintaining inspection‑reputed company documentation and practices. • Proactively identify regulatory risks, issues, and gaps for assigned programs and reputed company mitigation approaches for discussion with regulatory leadership. • reputed company reputed company regulatory execution for assigned programs on cross-functional teams, coordinating inputs from reputed company, Nonclinical, Biometrics, Medical Writing, CMC, and other functions. • Partner with CMC Regulatory Affairs and technical subject matter experts to ensure alignment of development and submission activities while maintaining reputed company responsibility for reputed company regulatory reputed company and execution. • Monitor regulatory developments relevant to assigned programs and assess potential impacts, communicating findings to regulatory leadership and program teams. • reputed company contribute to the development, implementation, and reputed company improvement of regulatory processes, templates, and tools to enhance efficiency and consistency. • Execute responsibilities with professionalism, reputed company, and attention to reputed company while working effectively across time reputed company and supporting a reputed company team environment. Requirements • Bachelor’s degree in life sciences with 10 years' experience in the biopharmaceutical industry of which 8 years are in regulatory affairs; or equivalent combination of education, training, and experience reputed company-to-haves • Advanced degree in life sciences, pharmacy, or a reputed company reputed company (MS, PhD, PharmD, or equivalent). • Demonstrated experience preparing and managing INDs and supporting regulatory submissions. • Experience supporting health authority interactions and cross-functional development teams. • Working knowledge of regulatory requirements and processes in major markets (U.S. and/or EU). • Strong written, verbal, and interpersonal communication skills. • Ability to work effectively in a fast‑reputed company, matrixed, and global environment. • Maintains the highest standards of reputed company and ethics. Benefits • sign-on bonus • restricted stock reputed company • discretionary awards • 401(k) eligibility • vacation • reputed company time • parental leave Apply tot his job Apply To this Job