Senior Director, Regulatory Affairs

## Senior Director, Regulatory Affairs Apply:
Hybrid:
USA
- Pennsylvania
- North Wales (Upper Gwynedd):
Full time:
Posted Yesterday:
End Date:
October 2, 2026 (12 days left to apply):
R418196
** Job Description
** The Senior Director manages a team of promotional regulatory professionals in the regulatory review of U.S. promotional materials for assigned products.
*
* Summary of Responsibilities:

*** Leads a team of promotional regulatory reviewers (senior specialists, associate directors, and individual contributor directors) to provide regulatory strategy across multiple therapeutic franchises for pipeline and in-line products that competitively positions our company's products, consistent with applicable FDA regulations and company policies for US advertising and promotion. Ensures strategy is aligned with overall corporate strategy and organizational goals.  The senior director will be responsible for providing a regulatory risk assessment and managing escalations with senior leaders.
* Partners with commercial and other stakeholders to develop a promotional regulatory strategy and product positioning that aligns commercial strategy with regulations. Drives optimal regulatory strategy, planning and delivery for advertising and promotion to support the overall business goals for therapeutic area(s) of focus.  Serves as critical leadership point of contact for assigned brands and associated escalations, as needed.
* Serves as critical partner with HH, Legal and Medical on cross-divisional transformation work inclusive of process redesign and technology enablement.
* Oversees direct report’s product assignments and ensures collaboration and a cohesive and integrated regulatory strategy from early development through approval and marketing. Provides guidance and coaching to direct reports on their input to product labeling, global regulatory team strategy, adequate support of promotional messaging and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.

Ensures direct reports are compliant with corporate policies and complete all required corporate and compliance training.
* Demonstrated ability to impact and drive regulatory decisions with senior company leadership and with FDA.  Helps shape regulatory policy with OPDP and APLB on emerging topics and innovative technologies.
Serves on external promotional regulatory planning committees and contributes to our company's regulatory leadership by presenting at leading external regulatory meetings (DIA, FDLI, RAPS etc.).
* Identifies the need for development, refinement, and implementation of department and corporate strategic initiatives that drive effective, compliant promotional regulatory review.
* Analyzes business needs and capacity and contributes to staffing discussions with Executive Director.
* Serves as a liaison with OPDP and/or APLB Team Leaders or reviewers for business-critical initiatives.
* Effectively interprets and communicates FDA perspectives to relevant company stakeholders and recommends policy and/or process changes as needed.
** Education Minimum Requirement:
*** Bachelor of Arts or Science Degree, with advanced degree preferred.  Strongly preferred to have a science-related degree such as biology, chemistry, nursing, pharmacy, social sciences, or QA/regulatory affairs.
** Required

Experience and Skills:

*** Minimum 12 years’ experience in pharmaceutical/biologics regulatory, clinical, medical, legal, and or marketing disciplines, including demonstrated advertising/promotional review work
* Minimum 6 years’ experience reviewing advertising and promotion materials or marketing programs for regulatory/legal compliance
* Expert understanding and…