Director / Senior Director Regulatory Affairs (Clinical)
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 the company's products.
- Develop and execute Clinical and Non-Clinical regulatory strategies.
- Provide regulatory leadership in support of the development and registration of the company's products with a forward-looking mindset toward a product's target product profile and ultimate prescribing information or product label.
- Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assess regulatory implications and develop the regulatory strategy for drug development and approval.
- 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.
- Coordinate, write, compile, as appropriate, document packages for regulatory submissions from development, preclinical and clinical areas per regulations/guidelines and company SOPs to support regulatory applications including investigational and marketing applications
- Review and approve investigator site regulatory documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to US FDA requirements and/or country requirements for initiation of clinical sites and drug shipments.
- Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues 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 including consultants and vendors
- Write, review, provide regulatory and technical input and ensure that documents pertaining to clinical and non-clinical information are prepared in line with the company policies, regulatory guidelines, and industry best practices
Skills and Requirements:
- BA/BS and/or advanced degree in life sciences
- 10 years relevant clinical regulatory pharmaceutical experience, including extensive knowledge of all aspects of the Global Development process (including NDA, BLA, MAA)
- Proven ability to communicate with executive management, external thought-leaders and operational staff
- Flexible attitude with respect to work assignments, and new learning
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.