Snr Director of Regulatory Affairs
Newark Metro Area, New Jersey
- Senior Director Level - Consultant of Regulatory Affairs .
- The Senior Consultant s ability to plan in collaboration with and execute in cooperation with cross functional teams is pivotal to success for the individual and the organization. The Senior Consultant must be able to clearly articulate defined goals, objectives and achievements with stakeholders within both cellular therapeutics and the greater Corporation as well as with external stakeholders. She/he must be capable of making strategic contributions to clinical development plans and also be expert at effectively managing interactions and relationships with regulatory authorities related to biopharmaceutical research, development and CMC activities. Of equal importance is the ability of the Senior Consultant to lead and to coach and develop junior staff to their full potential.
1. Provide regulatory expertise in developing U.S. and global regulatory strategies and operational plans for identified human cellular investigational products.
2. Provides strategic regulatory input and guidance for the Division ensuring the Division achieves its overall mission and objectives.
3. Provide leadership and guidance to senior executives on regulatory matters to progress and expand the biotherapeutics portfolio.
4. Evaluate emerging regulations and changing regulatory landscape for impact and provide strategic advice for the portfolio.
5. Serve as Cellular Therapeutics lead Regulatory person.
6. Identify issues and/or take on assigned projects that will impact regulatory affairs or projects and provide strategies for dealing with them.
7. Work closely with internal/external key stake holders to gain support and impart influence on our positions.
8. Key regulatory representative on various cross-functional teams as assigned.
9. Participate in Project and Portfolio Guidance Committees.
Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in inflammatory disease drug development, hematology/oncology, or cell therapy development, preferred.
8-12 years pharmaceutical/biotech industry experience (to include 6-8 years in Reg Affairs). Global experience very desirable. U.S. experience as lead interface with FDA necessary. E.U./other regional experience desired.
Thorough knowledge of the drug research, development, and commercialization process.
Demonstrated specific expert in one or more key areas Drug Development/ CMC/ Pharmtox/Cell Therapy/Biopharmaceutics/Clinical.
Inter-dependant partnering skills, team-orientated and ability to influence outcomes are necessary skills in the environment. A sensitivity and experience with non-domestic organizations / environment is necessary.