Senior Director – Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Director for the Science and Regulatory Advocacy team to support its International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) efforts.
The Senior Director, Science and Regulatory Advocacy, (SRA) will work under the direction of the Deputy Vice President and will serve as the SRA lead for key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC (to leverage synergies in support of ICH), and international priority markets.
The Senior Director is responsible for:
- Representing and serving PhRMA as the ICH Coordinator; managing and coordinating related PhRMA working groups. This includes working as a project manager, consensus builder and a portfolio manager to ensure moving pieces within ICH are aligned and coordinated with the advocacy strategies throughout PhRMA.
- Providing strategic direction and guidance to PhRMA’s standing, ad hoc committees and expert working groups focused on the development of internationally harmonized guidelines and related efforts in the US on quality, safety, efficacy and multidisciplinary Information Technology topics.
- Developing relationships with key external stakeholders such as regulatory bodies, sister industry associations (e.g., EFPIA and JPMA), global and regional harmonization organizations (e.g., APEC RHSC), and member organizations.
- Ensuring continuous advancement and coordination of strategic regulatory advocacy planning and execution in ICH and priority markets, including oversight and development of team member support to international regulatory harmonization strategies in PhRMA International’s regional/priority markets.
- Supporting integration and coordination of international regulatory policy priorities with US-focused priority areas inside and outside of SRA.
- Acting as primary point of contact and/or subject matter expert for internal and external stakeholders on SRA topics related to international harmonization and regulator capacity building.
Key Success Factors
PhRMA seeks a proactive, strategic thinking 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 ICH regulatory planning and advocacy expertise and be an organized, detail-oriented project manager with excellent writing skills. Demonstrated consensus building among internal and external stakeholders, decision-making and interpersonal skills are essential.
Professional Experience / Requirements
- Bachelor’s degree (Master’s degree in Pharmaceutical or Life Sciences, Chemistry, Medical Sciences, Public Health, Regulatory Sciences, Health Policy or related disciplines preferred);
- A minimum of 5+ years of relevant experience in drug discovery, development or regulatory affairs;
- Demonstrated knowledge of drug discovery, development and related regulations;
- Ability to inspire confidence within the organization and with external stakeholders;
- Strong project management experience with the ability to handle multiple projects;
- Excellent verbal, written, listening and presentation communication skills required;
- Must be willing to travel domestically and internationally; 4-8 trips per year once travel restrictions are lifted.
Who we are
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than $900 billion in the search for new treatments and cures, including an estimated $79.6 billion in 2018 alone.
Connect with PhRMA
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What we offer
In addition to a highly competitive salary and bonus program, various opportunities for reward and recognition and a platform of extensive benefits, PhRMA is committed to the development and overall wellbeing of our team members. We offer traditional (medical, dental, vision, flexible spending, life, AD&D, LTD, STD, LTC) and enhanced benefits such as parental leave, a wellbeing program, back-up care, health advocate service, employee assistance program and commuting benefits. We also offer a robust 401k plan with employer contributions upon the first day of hire and immediate vesting, a generous paid time off plan, seven paid holidays (plus inauguration day), half day Fridays preceding holidays and a paid winter break.
We are committed to the growth and development of our team members and offer many learning opportunities including an integrated on-boarding program, best-in-class leadership programming, tuition reimbursement at both the undergraduate and graduate levels, industry on-site and off-site training, and other management/professional development programs. Corporate social responsibility is also important to us at PhRMA. Our team members participate in organization-wide community service activities, fundraising drives and charitable athletic events.
We are committed to supporting our family of professionals at PhRMA and strive to create programs that help our team members manage the challenges of balancing a fast-paced career with their own personal goals.
Equal Opportunity Employer
PhRMA provides equal employment opportunities to all applicants without regard to race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, gender identity or expression, family responsibilities, genetic information, disability, matriculation, political affiliation or veteran status in accordance with applicable federal, state and local laws governing non-discrimination in employment.