Associate Director, Global Regulatory Affairs - GI & Inflammation

Objective / Purpose:
- Define, develop, and lead global strategies to maximize global regulatory success for complex and/or multiple projects.
- Provide strategic and tactical advice to achieve timely and efficient development and program maintenance while ensuring compliance with applicable regulatory requirements.
- Lead across department and R&D, contributing to cross-functional initiatives and influencing the field.
- Provide leadership and development for direct reports, including global regulatory leads.

Accountabilities:
- Lead Global Regulatory Teams (GRTs) and sub-working groups (e.g., Label Working Group); represent GRTs at project meetings; define strategy and provide tactical guidance; ensure strategy is updated and executed (or oversee direct reports/junior staff).
- Ensure global regulatory strategies are implemented and maintained as regulatory and business needs change; anticipate changes and adapt strategy.
- Keep colleagues, line management, and stakeholders informed of developments impacting regulatory success; communicate professionally and timely.
- Proactively anticipate risks and develop solutions; discuss with team/management and understand probabilities of technical success.
- Accountable for all US FDA submissions and approvals for assigned project(s) (or oversee direct reports); lead all submission types.
- Serve as direct point of contact with health authorities; lead/manage FDA meetings; manage direct reports/junior staff as needed.
- Coordinate with regulatory regional leads, other functions, and vendors to provide global regulatory submissions to local affiliates in compliance with local regulations and maintain product compliance.
- Oversee vendor responsibilities for regulatory activities/submissions within scope.
- Participate in or lead departmental and cross-functional task forces/initiatives; lead reviewer in due diligence for licensing opportunities.
- Partner with global market access colleagues on interactions with regulatory/health agencies/HTA bodies on product value evidence topics.
- Monitor and anticipate trends affecting regulatory and access environments to strengthen product development plans and adopt regulatory strategies timely.

Education & Competencies (Qualifications):
- Bachelor’s degree in a scientific discipline (strongly preferred).
- Advanced degree in a scientific discipline (PharmD/PhD/MD) (strongly preferred).
- 6+ years pharmaceutical industry experience, including 4+ years regulatory experience.
- Preferred: experience reviewing, authoring, or managing components of regulatory submissions.
- Solid working knowledge of drug development process and regulatory requirements; knowledge of FDA, EU, Canada, ROW; post-marketing knowledge is a plus.
- Ability to understand/interpret complex scientific issues and scientific data as related to regulatory requirements and strategy.
- Strong oral and written communication; timeline management; negotiation; integrity; adaptability.
- Demonstrated independence in regulatory strategy; proactive identification of regulatory issues; creative solutions including risk mitigation.
- Ability to work effectively with others and within global teams; bring teams together for common objectives.