Halozyme Therapeutics, Inc.
The Regulatory Affairs Specialist 2 (RAS 2) will provide support to the company’s internal and alliance programs for regulatory activities. The RAS 2 will assist with the coordination, planning, creation, review, and approval of...
Facilitate preparation and completion of documentation to support electronic or paper submissions (e.g., IND, CTA, NDA) to FDA and to ex-US regulatory agencies in collaboration with team members from other functional areas and more...
Biotest Pharmaceuticals Corporation
The Director-Regulatory Affairs, supervises departmental operations, developing staff, assigning and reviewing development projects and needs for facilities, to insure attaining corporate goals. Serve as liaison/representative for company's...
NewLink Genetics seeks a full time Director / Associate Director, Clinical Development, in NewLink’s immuno-oncology clinical development program. This individual will be expected to provide medical leadership and content expertise in collaboration...
Neurocrine Biosciences, Inc.
The Regulatory Director will influence organizational decisions that involve multiple groups and/or locations.
Essential Duties and Responsibilities (include but are not limited to)
Implement and Manage all Regulatory activities required to bring...
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic...
Management and leadership of the global regulatory development activities for assigned product(s). In this role the Director is responsible for representing Regulatory Affairs at core team and sub-team meetings and other scientific...
Reporting to the Vice President of Regulatory Affairs, the successful candidate will provide leadership in assuring compliance in regulatory requirements for successful drug development. Candidate will have primary responsibility for activities...
Vice President of Regulatory Affairs
Directs and leads all Regulatory Affairs activities for the company including leading our Regulatory Services business unit and our internally developed products. Incumbent will develop and...
Jazz Pharmaceuticals, Inc.
The Senior Manager, Regulatory Strategy will be responsible for registration and regulatory support of US commercial and development projects. He/she will support Jazz Pharmaceuticals’ efforts to obtain worldwide approvals to market our products. ...