What will you be empowered to do?
Senior Manager, Regulatory Affairs
Sunnyvale, California, United States
Who You Are
You are a highly skilled, solution driven regulatory affairs professional with expertise in managing the day-to-day activities of a dynamic regulatory affairs department. You are a clear and articulate communicator and a great listener and observer that can work effectively with other teams across the organization. In this role, you will combine regulatory expertise and knowledge of scientific issues to partner with and coach internal stakeholders by providing regulatory guidance needed for pre and post market compliance. You will ensure that data are identified, obtained and effectively presented for the registration of products worldwide.
Who We Are
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
What You’ll Do
- Develop global regulatory plans, identify risk mitigation strategies and influence project teams and subteams to maximize the likelihood of regulatory success
- Oversee the FDA regulatory submissions process, including development of strategy, submission structure, gathering submission materials from stakeholders, and direct negotiations with FDA review teams
- Assess new projects or product changes for regulatory classification (including Class 3, Class 2, Class 1, enforcement discretion or non-medical device)
- Proactively evaluate, interpret and communicate relevant global regulations, guidelines and evolving regulatory trends which impact 23andMe products and services, partner cross-functionally to translate regulations into sound business practices
- Represent regulatory affairs on various cross-functional business or product development teams to provide regulatory input, guidance, and support including design verification, and validation strategies to support all the regulatory aspects of the product development lifecycle
- Use knowledge of strategic regulatory concepts and company objectives to negotiate solutions with other stakeholders to resolve complex issues in creative and effective ways
- Assess reportability of complaints, and ensure events are processed in accordance with regulatory requirements
- Prepare and/or review regulatory submissions documents
What You'll Bring
- Minimum of a Bachelor's degree preferably in life sciences; an advanced degree is strongly preferred (MS, MD, PhD)
- Minimum of 7-10 years previous experience working in Regulatory Affairs relevant to OTC/DTC and IVD products
- 3-5 years experience with direct people management
- Demonstrated leadership and program/project management skills, including ability to effectively manage cross-functional teams
- Excellent communication and teamwork skills, and the ability to adapt and interface effectively with a wide range of stakeholders
- Problem solving skills and the ability to get to yes or no quickly
- Ability to understand and interpret scientific data, technical documents, professional journals and government regulations as it relates to strategy for assigned projects, and provides knowledge and expertise to guide teams in building an appropriate regulatory strategy
- Ability to write clear, understandable technical and regulatory documents
- Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation and style
- Flexibility to support changing assignments and priorities in an independent and reliable manner
- Travel 0 - 10%
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 firstname.lastname@example.org. 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.Back