Senior Policy Director

Employer
AstraZeneca Pharmaceuticals
Location
Gaithersburg, MD
Posted
Jun 12, 2018
Closes
Jun 22, 2018
Function
Executive, Director
Hours
Full Time
AstraZeneca: At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Senior Policy Director in Gaithersburg, MD , you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. The Senior Policy Director is responsible for US regional regulatory policy development and advocacy in cooperation with the Global Regulatory Affairs Therapeutic Area Vice Presidents. The Senior Policy Director provides a broad strategic view for regulatory policy issues impacting the US region and the regulatory authority of the FDA. The Senior Policy Director will collaborate with global counterparts through participation on the Global Medicines US Policy Network (GMUSPN) to develop and implement broad policy strategies that align with AstraZeneca business priorities. This person will have specialized knowledge permitting the individual to advise product development teams in the drug and biologic arenas, including biosimilars policy and will support policy advocacy efforts in the biologics CMC as a member of the GMUSPN. This person will also have experience regarding combination products, including those involving personalized healthcare approaches and/or digital health technologies. This person will work in collaboration with the Executive Regulatory Affairs Directors in assessing the US regulatory environment, and developing and implementing influencing plans that can have a favorable impact on the drug development paradigm for AZ's therapeutic product areas. In addition, they serve as internal experts on FDA regulatory policy and support product development teams on an ad hoc basis. This person will collaborate with Medical Affairs, Legal, Intellectual Property, Federal Government Affairs and Policy, and other key stakeholders that have a role influencing US policy and legislation development. This person will participate in various US trade association activities focused on influencing FDA related topics. This person may represent AstraZeneca on association sub-committees and workgroups to put forth and represent AstraZeneca's strategic and tactical interests. This person will contribute to development and maintenance of a listing of policy priorities that align with AZ business interests through participating on the GMUSPN. This person will take lead for assigned policy areas that require strategy and advocacy plans, action plans, and the development of related white papers that may be deemed useful. This person will participate in facilitating and/or leading US Policy Forum discussions focused on hot topics drawn from the US regulatory environment.