Director, Clinical/Non-Clinical Regulatory Affairs
Proclinical is currently recruiting for a Regulatory Affairs Director for a biosimilar company located in San Francisco, CA. Successful candidate will be responsible for providing global regulatory leadership in support of the Clinical and Non-Clinical development, registration, and life-cycle management of company products.
- Develop and execute Clinical and Non-Clinical regulatory strategies.
- Provide regulatory leadership in support of the development and registration of company products with a forward-looking mindset toward a product's target product profile and ultimate prescribing information or product label.
- Represent Regulatory Affairs at product development team meetings and coordinates regulatory document workflow between departments,
- Provide strategic regulatory leadership for programs, including regulatory requirements for INDs, development plans, clinical studies, study designs, study reports, NDA/BLAs, and product labeling.
- Work collaboratively within the department to seek department alignment on Regulatory strategies, project team advice, and submission operations as appropriate, across programs.
- Coordinate, write, and compile documents for regulatory submissions per regulations/guidelines and company SOPs to support regulatory applications including investigational and marketing applications.
- Maintain Regulatory document control system.
- Acquire and maintains current knowledge of applicable regulatory requirements in the geographic and discipline areas relevant to assigned projects.
- Responsible for interactions with regulatory authorities as needed.
- Participate in department initiatives to improve standards and systems internally and maintain relationships with other departments.
- Develop and implement department policies.
- Manage challenges proactively and collaboratively.
Skills and Requirements:
- BS/MS or PhD a in life sciences field.
- 6-10 years relevant regulatory pharmaceutical experience.
- Extensive experience in Regulatory Affairs including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities.
- Ability to manage multiple and varied tasks in a fast-moving environment.
- Sense of urgency and perseverance to achieve results.
- Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, and working collaboratively with partners are required.
- Must have a positive and flexible attitude and be eager to learn new areas of product development.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.