Regulatory Affairs Director
Proclinical is currently recruiting for a Regulatory Affairs Director with a biotechnology company located in Gaithersburg, MD. Successful candidate will implement and coordinate all aspects of regulatory activities as needed to support the continued development of the company's investigational vaccines.
- Assist with regulatory submission strategies for investigational and ultimately commercial vaccine products.
- Lead key regulatory activities, including planning, writing, and reviewing of documents necessary to support regulatory submissions, including INDs and BLAs, meeting requests, briefing packages, and responses to queries from regulatory agencies.
- Ensure that overall project timelines support the coordination and preparation of timely submissions.
- Communicate and coordinate with relevant functional groups and project team members to identify and ensure the preparation of required documentation and data needed for regulatory submissions.
- Act as primary regulatory representative on internal project teams and for other project development activities to ensure that development activities support and comply with the relevant regulatory requirements.
- Maintain up-to-date working knowledge on relevant regulatory regulations, guidance and the current regulatory environment. Provide updated information on regulatory issues to project teams and other personnel.
- Establish regulatory processes and procedures and provide training to other departments.
Skills and Requirements:
- Bachelor's degree preferably in a scientific field. An advanced degree is desirable.
- A minimum of 8-10 years in the biotechnology industry with at least 6 years in Regulatory Affairs.
- Background in vaccine development with knowledge of the vaccine development process highly desirable.
- Good understanding and experience with current GMPs and regulatory expectations for investigational products and clinical trials.
- Experience with CTD format and content.
- Ability to work independently and within a group setting and to interact effectively with different functional departments.
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
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 (+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.