Director of Regulatory Affairs

Location
Berkeley, California (US)
Posted
Feb 21, 2018
Required Education
Bachelors Degree
Position Type
Full time

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, and basic and applied biological research. The five-year-old company has developed a best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position.

Caribou seeks an experienced and highly motivated Director of Regulatory Affairs to join its team at its research and development facility in Berkeley, CA. The ideal candidate will interact with management and others to manage a portfolio of products for regulatory filings.  The Regulatory Affairs Director must enjoy working in a fast-paced and highly cross-disciplinary environment while interacting with our team of scientists and researchers.  This seasoned professional will be implementing a regulatory strategy for the internal development programs.  In addition, the individual will implement and manage internal regulatory processes, prepare documents for regulatory submissions in compliance with health authority regulations, and interact with and manage relationships with agencies and external subcontractors.   The position will report to the CSO and will have regulatory accountability across all development programs.

Responsibilities

  • Lead internal regulatory affairs on all relevant and current global guidelines and navigate effective paths to therapeutic approvals
  • Provide guidance on regulatory mechanisms from pre-IND to product development on preclinical, clinical and CMC elements
  • Manage and execute all regulatory activities, including submission and maintenance of US and international regulatory filings
  • Implement quality assurance methodologies and oversight for product development, including the creation of SOPs
  • Serve as primary liaison with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the preparation for and facilitating sponsor interactions at regulatory meetings, and ensuring appropriate follow-up
  • Work closely with external consultants and CDMOs on quality assurance and product manufacturing


Job Requirements

  • BS degree in the life sciences required, while an advanced degree (MS, PhD, MD) is desired
  • Minimum 5+ years of regulatory affairs management experience  
  • Quality assurance experience desired Practical experience working in cell-based therapeutics and/or oncology is desirable
  • Solid working knowledge of the drug development process and knowledge of FDA/EMA/ROW regulatory submissions and maintenance requirements
  • Strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communication skills
  • Solid understanding of cGXP regulations and able to provide guidance on regulatory compliance
  • Must be detail- and goal-oriented, quality conscientious and customer focused

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.