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Senior Regulatory Operations Coordinator
South San Francisco, California, United States
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.
23andMe's Therapeutics team is committed to discovering and developing new therapies that can offer significant benefits for patients. This dedicated research and development group in South San Francisco identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs for disease areas with high unmet need.
We are seeking an outstanding Senior Regulatory Submissions Coordinator to join a collaborative, cross-functional Development organization focused on bringing genetically-validated therapies to patients with high unmet needs. Successful candidates will have experience independently coordinating, editing and submitting regulatory documents.
More information about our Therapeutics team is available at https://therapeutics.23andme.com/.
What you’ll do
- Represent Regulatory Operations on 23andMe therapeutics project teams; provide input to project teams by understanding project needs and aligning Regulatory Operations requirements on timing, process, and procedures for submission activities
- Coordinate with Regulatory Affairs, Project Management, Medical Writing, IT, and other functional areas as needed to support Regulatory Operations objectives
- Manage customization of submissions including INDs/CTAs/IMPDs/ODDs and briefing packages, providing editorial, formatting, and other support as needed to achieve compliant, high-quality, timely submissions
- Oversee outsourced regulatory publishing activities and develop/manage processes for handoffs from other functional areas, including research/discovery, CMC and clinical, to vendors
- Manage effective and up-to-date Regulatory Information Management and Archiving systems; maintain initial applications and amendments across global development programs
- Serve as a representative to Regulatory Agencies on technical aspects of eCTD/NeeS filings
- Develop and provide training on Regulatory Operations and publishing SOPs and best practices; support due diligence and inspection readiness activities as needed
- Maintain and expand current knowledge of regional regulatory publishing requirements and precedents that may affect company filings
What you’ll bring
- BS, MS or PhD in life sciences or a relevant field.
- Familiarity with FDA regulatory processes (plus EU and RoW CTA/CTN, preferred)
- Experience supporting cross-functional development or CMC projects with regulatory submissions (eg, IND/CTA; NDA/BLA/MAA), submission data management and maintenance
- Regulatory project management experience
- System administration experience with Veeva Vault or similar content management platform preferred
- Collaborative relationships with key parties (e.g., Regulatory Agencies, vendors)
- Knowledge of one or more of our therapeutic and disease areas, key regulatory requirements, core submissions processes, standards and technologies used by Regulatory Affairs.
- Expertise in processing electronic and non-electronic routine and non-routine regulatory submissions. Developing more advanced capabilities in independently developing certain sections of regulatory submissions.
- Participation in departmental and cross-functional strategic planning
- Support team decision-making by managing regulatory submissions and document management in strict compliance with company and regulatory requirements, and by following predefined processes and procedures.
- Consistent communication in a manner that builds trust and enhances alignment with others.
- Routinely go out of your way to help others. Take initiative to support the whole team. Appreciate and leverage diversity across the team. Highly regarded as a trusted advisor to cross-functional partners and stakeholders.
- Proactive and highly self-motivated with emerging analytical and troubleshooting skills.
- Self-aware, receptive to and learns from feedback.
Note: Job title will be commensurate with experience and academic credentials
23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand, and benefit from the human genome. The company was named by Glassdoor as one of the Best Places to Work in 2019, MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 23andMe, Inc. is located in Sunnyvale, CA. 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 email@example.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.Back