Manager/Senior Manager - Regulatory Affairs
600 Townsend St,120E SF, CA 94103
Bayside Solutions is seeking Manager/Senior Manager - Regulatory Affairs to be part of our client’ s team in South San Francisco. This is an opportunity to work with clinical company aiming at developing oral recombinant vaccines.
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.
Manager/Senior 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:
- Partners in the preparation of submissions to regulatory authorities beginning with the pre-IND stage continuing through the clinical development stage (e.g., IND submissions, information amendments, annual reports, EU Clinical Trial Applications, IMPD, etc.)
- Coordinate publishing tasks with external partner for electronic submission activities (eCTD format)
- Coordinate, track and assist in preparing responses for Regulatory Agency requests to ensure commitments are met for all clinical programs
- Assist in the development and maintenance of departmental processes, SOPs and other standards relating to regulatory affairs such as document templates, style guidelines, version control procedures, and document archiving.
- Works independently with minimal direction, identifies project needs, creates regulatory project plans & timelines
- Bachelor’ s degree (or higher) in life sciences/scientific discipline
- 5-8 years of biologic/drug regulatory affairs experience
- Must demonstrate ability to collaborate with others and take initiative to improve processes for regulatory operations
- Proficient in eCTD submissions and publishing requirements
- Experience in filing INDs, CTAs for clinical studies; NDA/BLA experience a plus
- Familiarity with CBER and CDER; vaccines and small molecule experience a plus
- Knowledge of US, EU and ICH regulatory requirements and ability to apply operational knowledge to development projects
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- High level of proficiency in relevant software (i.e., MS Word, MS Office, Adobe, Document Management Systems, eCTD Publishing or similar systems)