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.

• 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.

• 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.

On‑site in Summit, NJ;
Monday through Friday standard business hours (flexible with approval).

• 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.

Anticipated to close 60 days from posting or sooner if filled or closed.