Manager of Regulatory Operations
409 Illinois St. San Francisco, CA 94158
Bayside Solutions is seeking a Manager of Regulatory Operations for their team in San Francisco. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and novel therapies for unmet diseases
The Manager of Regulatory Operations will ensure that communications to and from Global Health Authorities, Partners, and CROs are logged and archived to the appropriate databases, systems, and/or repositories. This role will play a key role in the strategic development and implementation of Regulatory Infrastructure such as a Qualified Regulatory Document Management Systems, In-house Databases, and Tools that support the Regulatory Affairs Department activities. This role will be integral in the continued development of processes and tools to support eCTD submissions on a daily basis.
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 atwww.baysidesolutions.com.
Manager of Regulatory Operations
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
- Supports daily submission activity, including (but not limited to) the assembly of Regulatory Submissions to US FDA in eCTD format.
- Supports ex-US submission activity to global health authorities, including (but not limited to) the preparation, formatting, and QC of documents being submitted global health authorities in the Asian and EU regions through CROs and Partners.
- Review and format document according to Regulatory Operations standards. Troubleshoot and resolve complex document issues.
- Gather information in support regulatory submissions for drugs products.
- Maintain and fix Regulatory System and Database issues (e.g., SharePoint, Veeva, etc.).
- Provide oversight for the archiving of Regulatory information to the Regulatory Archiving Inbox. Duties include archiving all Health Authority communications received for global health authorities either directly or from affiliates. These items are archived in both the DMS and Hardcopy Archive room.
- Plays an integral role in the QC of Regulatory Documents and Submissions.
- Provides support and training on custom authoring and formatting tool.
- Provides strategic writing, development, and implementation of department-wide SOPs, policies and/or work processes to streamline all submission activities and standardize interactions with other departments assists in typing, formatting, editing, proofing, creating and manipulating complex tables, converting text and graphics, scanning, bookmarking and hyperlinking.
- Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval Provides oversight and participates in the maintenance of the submissions archive room and electronic submission repositories
- Trains junior staff members
- 5-7+ years of pharmaceutical industry experience
- 5+ years in regulatory affairs, with demonstrated ability to interact with cross-functional groups
- Outstanding interpersonal, planning and organizational skills.
- Have a passion for quality and an impeccable detail orientation
- Bachelor' s degree and/or equivalent work experience
- Strong technical skills, including knowledge of IT systems and document management concepts.
- Proficiency in relevant systems and software, including eCTD software, Document Management Systems, Veeva, MS Access, SharePoint, Microsoft Office, and Adobe Acrobat Knowledge of FDA requirements for regulatory submissions (such as eCTD).
- Excellent writing, verbal communication skills and proven successful management abilities
- Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
- Expert in preparing documents and building Early Stage Development (IND/CTA) and Late Stage Development (NDA/MAA/NDS/BLA) submissions in the eCTD software