Regulatory Affairs Manager (PRC)
Redwood City, CA | Contract-to-Hire
Bayside Solutions is seeking a Regulatory Affairs Manager (PRC) to be a part of our client’ s team in Redwood City. Our partner is a biopharmaceutical company focused on the discovery, development and commercialization of medicines for patients with conditions that are often overlooked and undertreated.
The Regulatory Affairs Manager will be responsible for regulatory review of advertising and promotional material and representing Regulatory Affairs on the Promotional Review Committee (PRC). The ideal candidate will have a BS degree or higher in science or law, 5+ years’ of experience in Regulatory Affairs, and be proficient in PRC software.
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 (PRC)
- The opportunity to work with a company that has products in the development pipeline, as well as a successful marketed product.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, dental, vision, sick time, and 401K benefits.
Summary of Responsibilities:
- Serve as the primary regulatory reviewer on the Promotional Review Committee.
- Ensure regulatory compliance for all promotional materials, from content through FDA submission.
- Work with other PRC members to generate practical advice, options and risk analyses for PRC customers.
- Provide U.S. regulatory support for affiliates as needed.
- Review protocols, reports and other supporting documentation (i.e., quality, safety, efficacy, and labeling) to be included in regulatory submissions (e.g., IND, CTA, NDA, MAA) for accuracy and completeness and compliance with applicable regulations and guidance as well as SOPs, where appropriate.
- Independently manage routine regulatory submissions (e.g., Annual Reports, DSURs, Investigator Updates, etc.).
- Assist with managing regulatory agency interactions, document preparation, co-ordination of meeting rehearsals and minutes.
- Coordinate with other Regulatory personnel and personnel from other departments, as required, to complete assigned projects.
- Inform Regulatory personnel and personnel in other departments of new regulatory guidance and regulations.
- BS or higher degree in science or law, or equivalent, with at least 5 years’ of experience in Regulatory Affairs, or equivalent work experience.
- Experience in regulatory review of promotional materials and in other areas of Regulatory Affairs.
- Strong knowledge of promotional requirements, guidance, and changing regulatory climate and landscape.
- Shows strong initiative and drive.
- Must be an organized self-starter who is able to anticipate departmental needs.
- Excellent interpersonal and communication skills are essential. Ability to work successfully within a cross-functional team.
- Must be able and willing to work in a fast-paced environment while handling multiple priorities.
- Must be flexible, detail-oriented, and possess excellent analytical and problem-solving skills.
- Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat and PRC software.