Director, Regulatory Strategy

Responsibilities:
- Drive development and implementation of global regulatory strategies aligned with asset/corporate goals and health authority requirements.
- Ensure timely preparation of organized, consistent, scientifically valid regulatory submissions; translate regulatory requirements into practical plans.
- Communicate clearly and proactively with stakeholders to reduce regulatory risk and implement mitigation strategies.
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence and research to guide study/asset teams; provide risk assessments and recommendations for regulatory scenarios (including possible expedited pathways).
- Represent Regulatory Affairs on multi-disciplinary teams to set development and regulatory strategies for early and late-stage programs.
- Plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions with external vendors.
- Review clinical trial documentation (e.g., protocols, informed consents, clinical study reports) for regulatory compliance and alignment with objectives/strategy.
- Coordinate, author, and evaluate documents submitted to health authorities to ensure completeness, organization, quality, appropriate messaging, and regional regulatory compliance.
- Oversee preparation and completion of regulatory submissions (electronic and paper), including INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, and NDA/BLA.
- Contribute to processes/procedures (develop and author internal work instructions and company SOPs).
- Lead multiple assets and/or studies as assigned.
- Liaise internally with functional departments; externally with vendors, licensors, consultants, and joint development collaborators.
- Directly supervise employees.

Qualifications:
- Bachelor’s degree in a related discipline + minimum 13 years related experience; or Master’s + 11 years; or PhD + 8 years; or equivalent education/experience.

Skills/Experience:
- Ability to develop/manage plans, timelines, performance standards; balance commitments and overcome challenges to deliver high-quality results.
- Extensive knowledge of the regulatory framework and industry practices; ability to develop innovative approaches for complex work.
- Strong verbal and written communication; confident one-on-one and cross-functional presentations; timely, appropriate updates.
- Strong interpersonal skills; ability to accommodate differing views to reach resolution.
- Ability to manage teams, facilitate alignment, achieve objectives, and build productive stakeholder relationships.
- Advanced analytical/problem-solving skills; regulatory expertise for cross-functional teams; understand long-term impacts of decisions.
- Job complexity: proactively assess workload/priorities; plan/execute multiple activities; use alternative methods/contingencies; design solutions for project challenges with broader impact.

Working conditions:
- Travel approximately 15%.

Benefits (if offered in the posting):
- 401k with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus program (or sales-based incentive plan for field sales staff).
- Opportunity to purchase company stock; long-term incentives.
- 15 accrued vacation days (first year); 17 paid holidays including a winter shutdown in December; up to 10 sick days per calendar year.

Application instructions:
- N/A (not provided).