Head of Regulatory Affairs

Who Are We?

Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. 

We are looking for exceptional team members who want an active role in building a rapidly growing biotech.

Title: Head of Regulatory Affairs

Location: Remote or Office Based (South San Francisco, CA, US)

Opportunity:

Epicrispr Biotechnologies is seeking a highly motivated Head of Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.  This role will be responsible for coordinating all aspects of regulatory strategy, integrations and filings.  We are looking for an exceptional team member who wants an active role in building a rapidly growing biotech.  This is a leadership position that will play a critical role in the successful development of Epicrispr Biotechnologies' therapeutic candidates.  The successful candidate will embrace our company’s culture which values humility, is driven by curiosity, thrives on diversity and aspires to continuous improvement.  The role will report into the Chief Medical Officer.

 

Roles and responsibilities:

• Lead, define and manage the strategic regulatory direction for Epicrispr Biotechnologies' pipeline
• Establish the regulatory pathway to successful IND/CTA filings in complex programs using a novel epigenetic editing technology
• Interface and collaborate with cross-functional colleagues including CMC, nonclinical, and clinical research and development and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities
• Collaborate with and manage various regulatory consultants in the near term, and help grow an internal team in the longer term, for executing the company’s regulatory strategy
• Serve as the main liaison between the company and global regulatory agencies, acting as the primary point of contact for all regulatory matters.
• Develop and coordinate high quality submissions to enable global clinical trials and approvals of the company’s innovative therapeutic candidates 
• Monitor and interpret changes in regulatory requirements and industry trends to inform strategic decision-making
• Oversee the preparation and submission of regulatory documentation, ensuring accuracy and completeness.
• Provide expert advice on regulatory issues to senior management and contribute to overall business strategy

 

Qualifications:

• Bachelor’s degree or higher in life sciences
• Director: Minimum of 7 years of experience in the biotechnology and/or biopharmaceutical industry (Master’s/PhD with 5+ years of experience); Sr. Director: Minimum of 10+ years of experience in the biotechnology and/or biopharmaceutical industry (Master’s/PhD with 7+ years of experience) 
• Minimum of 5 years of experience in biotechnology and/or biopharmaceutical industry in a Regulatory affairs capacity
• Experience with submissions through FDA’s CBER/OTAT or ex-US equivalents across various aspects of an investigational gene therapy product’s life cycle, including interactions before IND/CTA, IND/CTA filing, during clinical development, and/or for approval
• Strong organizational skills and drive for excellence
• Excellent verbal and written communication skills and proficiency in presenting regulatory strategy, plans, and/or updates to internal and external stakeholder audiences
• Deep understanding of gene therapy products’ regulatory requirements
• Proven success interacting cross-functionally in a dynamic environment
• Ability to be onsite at least approximately every 8 weeks
• Strong leadership and interpersonal skills, with the ability to work effectively across diverse teams.
• Strong analytical and problem-solving skills, with a strategic mindset.

 

Preferred Qualifications:

• Expertise and experience in regulatory affairs involving CRISPR-based or other gene editing/gene therapy products
• Advanced degree in life sciences
• Creative problem solver

 

Compensation:

$210k - $280k / year

Please be aware: the final compensation package, including salary and benefits, is subject to change and will be determined based on market value, your experience, qualifications, and the needs of our team.

Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.

Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.