Sr. Manger Regulatory Affairs
770 Lindaro Street San Rafael, CA 94901
Bayside Solutions is seeking a Senior Manager Regulatory Affairs to be part of our client’ s team in San Rafael. 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.
Sr. Manager Regulatory Affairs
- 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:
- The Senior Regulatory Affairs Manager is responsible for clinical and nonclinical aspects of domestic and international regulatory affairs to support global commercialization efforts and life-cycle management for multiple commercial programs.
- Exciting opportunity to join the Regulatory Clinical/Nonclinical group and gain global marketing application experience for multiple orphan products!
- Possibility for this position to expand scope into future preclinical/clinical development programs
- Provide clinical/nonclinical regulatory strategy and content to support preparation, submission, management and maintenance of domestic and international regulatory submissions including: INDs/CTAs and amendments; global Marketing Applications (MAs) and amendments/supplements; Orphan drug applications; Expedited review requests; Post-marketing requirements/commitments and Annual Reports.
- Provide strategic regulatory insight on clinical/nonclinical aspects of programs and ensure implementation of regulatory concepts within the global regulatory team and cross-functional project teams
- Assist in coordination and preparation for global health authority meetings and associated briefing documents/presentations
- Ensure compliance with existing product licenses (ie, annual reports – IND, PMR, BLA/NDA, DSUR/PBRER, RMP) fulfillment of post-marketing requirements and commitments; and maintain master CTD content
- Participate/facilitate relevant functional area and project team meetings
- Review documents (SOPs, protocols, and reports) related to clinical or nonclinical studies
- Continues to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics
- Exercise discretion and independent judgment in the performance of the above duties
Summary of Qualifications:
- BA/BS degree in life sciences
- Advanced degree a plus
- Rare disease experience is desirable
- Prior experience in the metabolism or endocrinology therapeutic areas is desirable
- 8-12 years of industry experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry with a clinical and nonclinical emphasis
- Skilled at gathering regulatory information and developing product approval strategies
- Proven track record of managing critical projects as a part of an interdisciplinary team
- Proven track record of successfully interacting with regulatory health authorities
- Prior experience managing regulatory submissions to deadlines
- Thorough understanding of relevant drug development regulations and guidelines
- Outstanding interpersonal and communication (written and verbal) skills
- Effective task planning and coordination abilities
- Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel)