Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Director for the Science and Regulatory Advocacy (SRA) team to support its regulatory advocacy portfolio efforts related to the US regulatory environment and related regulatory systems.
The individual will report to the Deputy Vice President of SRA and work with colleagues across the organization to provide strategic direction and guidance to PhRMA’s standing or ad hoc committees and expert working groups on issue areas such as the New Molecular Entities (NME) program, breakthrough therapies, expedited regulatory pathways, REMS, combination products and generic products. This includes ensuring the successful execution of regulatory advocacy initiatives and acting as the primary point of contact and/or subject matter expert for internal and external stakeholders.
The Senior Director is responsible for:
· Driving the development, evaluation and execution of select domestic regulatory environment advocacy priorities with colleagues PhRMA-wide.
· Development and execution of strategic regulatory environment projects and initiatives to include performing background research, soliciting member company input and actively facilitating cross-functional discussions within PhRMA and with PhRMA member companies, external stakeholders, and US and international science and regulatory bodies. S/He will create project plans, manage deliverables and execute initiatives.
· Developing and presenting project proposals and outputs to SRA and PhRMA leadership and leadership committees; serving as a credible and compelling subject matter expert who can integrate the vision of select initiatives related to regulatory environment advocacy into SRA and PhRMA priorities.
· Managing the relationship and administration of relevant standing and ad hoc committees and working groups.
Key Success Factors
PhRMA seeks a proactive, confident and action-oriented individual who is passionate about contributing to the health care challenges we face today. Key success factors for this role include a strong sense of team and collaborative focus. The preferred candidate will bring substantive regulatory expertise and be an organized, detail-oriented, self-starter with excellent writing skills and the ability to convey content in an audience-appropriate and compelling manner. Demonstrated consensus building, decision-making and interpersonal skills are essential. This is a highly visible, fast-paced position that is both internally and externally facing. Accordingly, the successful candidate should be adaptable, able to reprioritize and shift gears quickly, comfortable in a high-pressure environment and be politically savvy, diplomatic and responsive.