Caribou Biosciences, Inc. is a leading company in CRISPR genome engineering located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development, agricultural biotechnology, industrial biotechnology, basic and applied biological research. The six-year-old company has developed a best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position.
We are seeking a Regulatory Affairs and Quality Assurance facilitator to join our RA/QA team in Berkeley. The ideal candidate will interact with team members across the organization and provide regulatory and QA support to the Company. The specific job title will be dependent upon background and experience.
Responsibilities will include:
- Electronic assembly, publishing and submission of regulatory dossiers including INDs, CTAs, BLAs, supplements, periodic reports and amendments/supplements to these applications
- Implementation of document control system for quality documents and regulatory submissions
- Select vendors for the publishing in eCTD format. Act as primary liaison with outside vendor to coordinate the assembly and publishing of the IND filing. Maintain document preparation tracker for more complex submissions, including follow-up with authors/reviewers to maintain timelines.
- Serve as the Regulatory Project manager, take meeting minutes, coordinate response(s) to questions, and delineate roles and responsibilities for the regulatory submission deliverables
- Participate on cross-functional project teams for the development and preparation of regulatory documentation
- Support VP of RA/QA for budget planning, tracking hiring (contractors and FTEs), training and department initiatives
- Evaluate, troubleshoot and implement relevant software and hardware (e.g., Adobe Acrobat, Microsoft Word, ISI Toolbox, Veeva Vault Quality Docs, OmniFILE Publisher, OmniTEMPLATES, submission validation and viewer tools)
- Other special projects as assigned
Candidate must possess:
- Bachelor's degree, Master’s degree or equivalent experience
- Minimum of 7 years of experience in pharmaceuticals or biotechnology and 4 years of experience in direct regulatory operations
- Working knowledge of laws, regulations and guidelines is essential. Experienced in filing INDs, BLAs / NDAs in electronic formats
- Proficient in related computer systems and publishing systems. Strong understanding of current and new technologies designed to enhance business processes and practices
- Demonstrate understanding of regulations and guidelines governing electronic submissions and trends in Regulatory Information Management. Expert Regulatory knowledge of records management concepts, computer system validation, and submission-related regulations, including electronic submissions
- Excellent organizational, prioritization and planning skills. Ability to work independently on projects and initiatives internally and with external vendors
- Able to manage conflicting priorities and adhere to tight timelines
- Excellent oral and written communication skills
- Well-developed problem-solving skills
- Good energy, enthusiastic, goal driven
- Maturity and ability to effectively facilitate change in an environment where the structure may evolve rapidly
- Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings
- Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions
- Background in Document Control
- Quality audit experience
- Regulatory Affairs Certification
- Experience working with CBER and therapeutic filings
Caribou Biosciences, Inc. is a dynamic start-up company, and the successful candidate must have the ability and desire to work in a fast-paced environment. For more information, please visit www.cariboubio.com. Caribou is on Twitter. Sign up to follow our Twitter feed @CaribouBio.
Caribou offers a comprehensive compensation package, as well as generous paid time off in addition to Company-observed holidays. The Company provides medical, dental, and vision insurance, along with a 401(k) retirement savings plan which includes matching employer contributions. Caribou promotes a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.
Caribou is an equal opportunity employer and does not unlawfully discriminate on the basis of race, color, religion, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, physical or mental disability, medical condition (as defined under California law), veteran status, sexual orientation, gender identity, gender expression, sex or gender (which includes pregnancy, childbirth, breastfeeding, or related medical conditions), taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.
Direct applicants only. No agencies please.