Associate Director, Health Authorities

Associate Director, Health Authorities Responsibilities Lead and manage Health Authorities direct reports; hire, train, coach, and monitor performance. Review clinical data, reports, and summaries for protocol, SAP, monitoring guidelines, data management plan, and trial documents. Provide input to clinical study design and reporting. Manage preparation of clinical sections for regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs, and other applications). Create and maintain health authorities project plans; support cross‑functional study preparation and documentation. Lead external stakeholder engagement (CROs, regulatory consultants, SMEs/KOLs) and draft high‑quality RFI responses. Prepare and assign responses to agency questions; assemble final submission packages. Train on Regulatory Affairs SOPs, processes, and templates; oversee review, QC, and finalization of application modules. Monitor and apply regional and local health authority guidance; interpret updates to mitigate agency queries. Govern version control (repository, naming conventions, change tracking, module approvals). Develop and maintain product‑development roadmaps; perform ad‑hoc cross‑functional duties. Qualifications BS in life sciences or a technical discipline plus 10+ years; or MS plus 8+ years; or PhD plus 6+ years of progressive, relevant experience. Experience managing staff. Experience with eCTD clinical module preparation and submission. Medical writing skill and experience organizing responses to health authority information requests. Preferred: regulatory submissions experience outside the United States. Skills and Abilities Expert knowledge of health authority guidance, clinical research and GCP, regulatory requirements, and clinical documentation. Strong leadership, organization, written and oral communication, and attention to detail. Ability to meet deadlines and manage ambiguity. Location / Schedule On‑site in Summit, NJ; Monday through Friday standard business hours (flexible with approval). Compensation & Benefits Discretionary bonus and equity. Annual base pay $185,000–$203,500. Medical, dental, and vision insurance. Wellness programs. Employee assistance program (EAP). Life, accidental death & dismemberment (AD&D) insurance. Short‑term and long‑term disability coverage. Flexible spending accounts (FSAs). 401(k) matching. 529 college savings plan. Paid time off, including 11 holidays; unlimited PTO for exempt employees; non‑exempt employees receive vacation, health, personal, and cultural days. Application Window Anticipated to close 60 days from posting or sooner if filled or closed. #J-18808-Ljbffr Scorpion Therapeutics