Exciting start-up focusing on the medical aesthetics industry is seeking a Senior Regulatory Affairs Manager to help develop and drive the company’s regulatory affairs program. While a partial remote role, we are seeking candidates in Southern California who are able to work in the office a couple of days a week.
This company offers an energetic, transparent work environment with an outstanding leadership team, as well as a very competitive compensation package that includes an annual bonus and equity shares.
Requirements for the Senior Regulatory Affairs Manager:
- Bachelor’s degree, master’s degree preferred
- 5+ years regulatory affairs experience in biotech or pharmaceuticals
- Strong working knowledge of regulatory submission requirements for global filings including US, EU, UK, Canada, Australia, Russia.
- Experience in systems, review, and approval of advertising and promotional materials for drugs and devices.
- Experience launching new drugs in more than one European country preferred
- Strong knowledge of pre-clinical/non-clinal studies required for approval of new drugs and biologics.
- Knowledge of manufacturing processes associated with drugs, biologics, and devices.
- Experience working with contract manufacturers and suppliers of regulatory services preferred
- Experience in working with regulatory documentation systems and IT systems for regulatory document maintenance.
- Strong organizational skills and a track record of accomplishment in managing multiple competing projects under tight deadlines.
- Detail oriented, goal driven and ability to follow through
- Excellent facilitation and creative problem solving skills
- Excellent communication skills, oral, written and electronic
- Demonstrated ability to prepare complex documents/submissions and presentations
Occupational Category: 11-9199.01 Regulatory Affairs Managers
: Please apply using the form or send your resume to Debbie Winkelbauer