The Head of Regulatory Affairs will lead the global regulatory strategy for multiple programs in oncology and orphan & rare diseases for a top-tier Pharmaceutical company with offices in the Boston, MA and Philadelphia, PA/NJ areas. The successful leader will manage relationships and interactions with US and ex-US agencies, represent the company with corporate partners and manage a team of reports to ensure achievement of key regulatory milestones during the drug development and approval phases. Additionally, they will provide regulatory guidance for various corporate wide teams/committees.
This person will have the ability to work in the Boston, MA or Philadelphia/NJ area.
Provide advice and guidance to staff regarding regulatory aspects of drug development.
Give strategic direction to Regulatory Affairs department; including mentoring and leading staff
Effectively communicating requirements and compliance obligations under laws, regulations, and guidance in the US and Europe
Directing and negotiating submissions (IND, NDA etc..) and approvals with regulatory authorities both in the US and Europe
Guiding and/or leading regulatory agency interactions, including communications and meetings
Strategizing, leading, writing and/or supervising the development of and submission of documents/dossiers to regulatory agencies to achieve development goals
Qualifications:
Pharmaceutical/biotechnology industry including extensive hands on global biologics strategy experience with a minimum of 10+ years in regulatory affairs
Experience in the development of therapies for oncology, rare (orphan) and/or extremely rare (ultra-orphan) diseases desirable.
Doctoral degree in Regulatory Science, Pharmacy or the Sciences preferred.
International regulatory experience preferred.
Comprehensive knowledge of applicable regulations.
Experience in interpretation of regulations, guidelines, policy statements, etc.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
Comprehensive knowledge of GCPs and GLPs.
Extensive experience in interfacing with regulatory authorities in the US and outside of the US.
