770 Lindaro Street
Industry: Clinical & Scientific
Job Number: 15924
Bayside Solutions is seeking a Regulatory Affairs Analyst to be part of our client’ s team in Novato. 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 Analyst
- 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:
- Review and inform on recently published global regulatory legislation and policies impacting development of treatments for rare diseases.
- Provide project management support to the policy team in generation of comments on draft guidance;
- Track Team memberships and involvement in policy trade associations and organizations
- Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.
- Lead certain policy cross-functional meetings including minutes and action items
- Provide strategic logistical support for managing policy calendars and deliverables.
- Develop and manage internal policy publications.
- Develop and manage dashboards for policy team initiatives
- Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.
- Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.
Summary of Qualifications:
- 5 + Years of Experience
- Bachelors or Masters’ Degree in biology or other life sciences discipline
- Experience in a regulated biotechnology or pharmaceutical environment; 1 year in Regulatory Affairs and/or policy
- Strong verbal and written communication skills
- Strong project management skills
- Proficient with computer and standard software programs
- Organizational skills
- Communication skills, excellent verbal, written and presentation skills
- Very strong attention-to-detail