Regulatory Affairs Manager
300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a Regulatory Affairs Manager to be part of our client’ s team in the North Bay. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Regulatory Affairs Manager
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Preparing clinical/nonclinical global regulatory submissions in accordance with applicable regulations.
- INDs or international equivalents and amendments
- NDAs, BLAs, or international equivalents and amendments
- Information related to clinical trials including protocols, investigator brochures and investigator information
- Annual Reports
- Representing the Regulatory Affairs function on assigned cross-functional project teams and to external partners
- Actively participate in regulatory sub-teams and lead meetings on defined topics with a clear objective
- Researching and interpreting global regulations to provide regulatory guidance to cross-functional groups
- Proactively identify and communicate potential regulatory issues/risks and recommend solutions to Regulatory Affairs management
- Assist in coordination of meetings with Regulatory Authorities and associated briefing document preparation, as needed
- Other duties as assigned
Summary of Qualifications:
- BA/BS degree in life sciences required. Advanced degree preferred.
- 3-4 years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry, preferably with exposure to the development phase of the product lifecycle
- Experience in management and submission of clinical/nonclinical global regulatory documents
- Experience in participating and representing Regulatory Affairs on clinical study management teams
- Thorough understanding of relevant clinical/nonclinical ICH and regional regulatory requirements, particularly for the development phase of product development
- Excellent communication (verbal and written) and interpersonal skills with the ability to communicate cross-functionally in a collaborative manner
- Attention to detail