Senior RA Manager
Proclinical is currently recruiting for a Senior RA manager for a leading global biosimilar company located in San Francisco, CA. Successful candidate will report directly to the Director, Regulatory Affairs or above and will be a key member of the Regulatory Affairs staff.
- Direct activities associated with global regulatory registration of medical devices and/or drug device combination. Direct submission for a variety of regulatory activities such as IND, INDa, BLA, sBLA, PAS and post-marketing safety reporting etc.
- Supervise maintenance of product license and ongoing activities related to compliance with regulations.
- Provide and coordinate provision of regulatory support to related project development teams. Serve as the Regulatory Affairs representative on project teams and assuring the progress of projects by providing guidance and feedback to the team. Preparing FDA submissions (INDs, NDAs, and BLAs). Maintain awareness and communicating with team members regarding changing regulatory requirements.
- Ensure complete and timely submission of regulatory documents to health authorities
- With the Director of Regulatory Affairs and the project team members, develop and implement strategies to design development activities that will facilitate approvals.
- Review and make recommendations regarding clinical study protocols and related clinical study documentation to ensure compliance with FDA requirements.
- Direct and support in the preparation of clinical, preclinical, and CMC information for regulatory submissions. Ensuring accuracy and quality of regulatory submissions by writing, editing, and reviewing, as necessary.
- Serve as the regulatory liaison with the FDA and other regulatory agencies for assigned projects.
Skills and Requirements:
- BS, or advanced degree, in life/physical sciences with 5+ years regulatory affairs experience within medical device and/or pharmaceutical industry.
- Deep understand and knowledge on Design Control and Design History File requirements
- Knowledge on electrical medical device requirements
- Regulatory submissions experience, ideally in all phases of product development, pre- and post-marketing. Specific experience with drug-device combination products would be a plus.
- Direct experience interacting with FDA (CDRH) is desirable. The Manager must have the interest in, and ability to, expand his/her areas of regulatory expertise and the ability to apply scientific principles to complex regulatory issues.
- Writing skills that facilitate development of documentation and reports required for regulatory submissions and compliance. A proven ability to evaluate, analyze and interpret reports and other documents for regulatory submissions is essential.
- A strategic as well as an operational approach with the ability to "think outside the box" and to manage multiple tasks in a fast-paced environment.
- Excellent problem-solving ability and organizational skills, while maintaining attention to detail. A high energy level, a willingness and ability to work in a hands-on capacity, to adapt and respond to a rapidly changing environment, and to work effectively in a project team environment.
- Effective verbal and written communication skills, excellent interpersonal skills, and a team approach.
- The ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.
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.