23andMe logo

Regulatory Affairs Manager - 23andMe

View Company Profile
Job Title
Regulatory Affairs Manager
Job Location
South San Francisco, California
Job Description

23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.

This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.

23andMe Therapeutics is seeking an outstanding Regulatory Affairs Manager to join a collaborative, cross-functional development organization focused on bringing genetically-validated therapies to patients with high unmet needs. 

Strategic and timely regulatory support is critical in the successful development of our novel therapeutics. In this role, the candidate will use their excellent communication skills and strategic regulatory experience to lead high quality, timely, and successful regulatory filings in partnership with cross functional teams and subject matter experts. The successful candidate will serve as regulatory lead for at least one development program, with the opportunity to progress in leading a portfolio of development programs. 

 

Who We Are

23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.

This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs into clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.

 

What You’ll Do

  • Serve as regulatory lead for at least one therapeutic development program, executing successful and timely regulatory filings.
  • Represent the regulatory function on cross-functional teams, leading regulatory plans and strategies through development and lifecycle.
  • Build partnerships with cross functional teams and subject matter experts to support knowledge sharing and development of regulatory strategies
  • Critically review documents for submission to regulatory authorities for completeness, accuracy, consistency, clarity, and sound scientific rationale. Identify risks and propose mitigation strategies. 
  • Lead successful management with Health Authorities for a program, including review process, maintenance, and commitments.
  • Contribute to regulatory processes, strategy, intelligence, sharing knowledge with regulatory and cross-functional teams.
  •  

What You’ll Bring

  • Degree in life science and/or regulatory science
  • 5+ years of experience in biotech or pharmaceutical industry, including experience as regulatory program lead
  • Experience leading regulatory submissions for drugs, with oncology experience preferred
  • Understanding of regulatory requirements for drug development in both US and ex-US
  • Strong attention to detail and excellent communication, prioritization, and organizational skills
  • Ability to work independently, solve complex problems, maintain tight timelines, and balance multiple deliverables simultaneously
  • Strong knowledge of electronic document and submissions standards, including eCTD structure

Note: Job title will be commensurate with experience and academic credentials.

 

About Us

23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.

At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.  If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at accommodations-ext@23andme.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.

Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.

23andMe Headquarters Location

Mountain View, CA

23andMe Company Size

Between 500 - 1,000 employees

23andMe Founded Year

2006

23andMe Funding Rounds

  • Post Ipo Equity

    $250,000,000 USD

  • Series F

    $82,500,000 USD

  • Corporate Round

    $300,000,000 USD

  • Series F

    $250,000,000 USD

  • Grant

    $1,700,000 USD

  • Series E

    $115,000,000 USD

  • Grant

    $1,400,000 USD

  • Series D

    $50,000,000 USD

  • Series C

    $9,000,000 USD

  • Series C

    $22,220,289 USD

  • Series B

    $14,200,000 USD

  • Series B

    $13,600,000 USD

  • Series A

    $8,953,320 USD