Our client, an exciting venture backed biotechnology firm, is currently seeking a Senior Regulatory Affairs Manager to join their team as they complete Phase II Clinical Trials. This organization has developed a combination medical device and biologics treatment for heart disease and is searching for the right person to lead their Regulatory Affairs efforts with the FDA, EU, and other Regulatory bodies.
This is an exciting opportunity to work with an organization that has a developed pipeline, stable funding, and a novel therapy which has the potential to save lives, and significantly improve the quality of life for millions of people.
The Senior Regulatory Affairs Manager will have a high level of autonomy and influence because they will be responsible for development of Chemistry, Manufacturing and Control (CMC) regulatory strategies and plans to transition the product to commercial manufacturing. They will develop, review and approve CMC procedures, policies, and guidelines, including the preparation and maintenance of regulatory SOP’s. Ultimately, they will be responsible for the submission of high quality regulatory documents and briefing packages to FDA as well as other global regulatory bodies.
This individual will report directly to the VP of Product Development and will be highly visible to upper management – therefore must be comfortable working in a fast-moving, highly-dynamic startup environment.
Qualified Candidates must have:
- Regulatory experience with BOTH medical devices and biologics
- Previous experience working with CBER (Center for Biologics Evaluation and Research) and CDRH (Center for Devices and Radiological Health) are critical
- Previous successful experience developing Phase II and Phase III plans and documentation
- Ability and willingness to work in a fast paced environment and handle multiple areas of responsibility
If you are interested in learning more, or know someone who may be qualified, please contact: