Senior Regulatory Affairs Manager

CITY: Princeton STATE: New Jersey COUNTRY: USA Essential Functions (Responsibilities):
This position will be responsible for handling regulatory activities for all assigned development products. These activities include: (1) preparing regulatory strategies (2) communicating to local and global project members what information is necessary to support submissions (3) reviewing, editing, and preparing documents and correspondence for DMF, IND, CTD, and supplement submissions (including annual reports) (4) mentoring more junior regulatory affairs members as appropriate. As necessary, the incumbent will contact appropriate FDA personnel including for the coordination, preparation and conduct of formal meetings and teleconferences to facilitiate drug development (IND) and FDA approval of NDA and sNDA submissions.
The individual provides regulatory strategy and support for drug development and the preparation, submission, and maintenance of DMFs, INDs, CTDs, and supplements for assigned projects. The individual will provide assessment for other related regulatory activities as assigned and will be expected to maintain current regulatory knowledge and understanding of health authority (primarily FDA) regulations and guidance. The individual will be expected to provide mentoring for more junior regulatory affairs members of project teams and as assigned.

Qualifications/Requirements:
Bachelor's degree (minimum) in Science; MS preferred. A minimum of eight years experience in drug regulatory affairs, clinical development and/or quality assurance. The candidate must be comuputer literate (e.g., MS Word, MS PowerPoint, MS Excel).
The individual must posess strong organizational, administrative, planning, and communication (both written and verbal) skills and GE values. The individual must be able to work both independently and as part of a project team.

Desired:


General:


We offer a competitive salary, outstanding benefits package and the professional advantages of an environment that supports your development and recognizes your achievements. We are an Equal Opportunity Employer.