Head of Regulatory Affairs
About the Company
Innovative therapeutics company
Industry
Pharmaceuticals
Type
Privately Held
About the Role
The Company is seeking a part-time Head of Regulatory Affairs to serve as a pivotal leader in regulatory planning and interactions with various agencies. The successful candidate will be responsible for leading the regulatory function, with a focus on early-stage therapeutic products. This role involves independently preparing and managing regulatory submissions, particularly IND/NDA submissions, and overseeing interactions with CDMOs to ensure that all studies are conducted at a high quality and in compliance with regulatory requirements for IND/NDA submissions. Experience in leading regulatory functions for early-stage therapeutic products is essential, and experience with siRNA and ASO platform technologies is a significant advantage. Applicants for the Head of Regulatory Affairs position at the company should hold a BS degree or higher and have over 10 years of relevant regulatory leadership experience. The role requires a candidate who can work independently, with a proven track record of writing IND/NDA submissions and interacting with regulatory agencies. The ideal candidate will be adept at managing the regulatory aspects of early-stage therapeutic products and be prepared to take on a leadership role in this area. The company is particularly interested in candidates who have experience with siRNA and ASO platform technologies. The Head of Regulatory Affairs will be a key figure in the company's growth, ensuring that all regulatory processes are in line with the necessary requirements for the development and approval of therapeutic products.
Travel Percent
Less than 10%
Functions
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