As a key member of Regulatory Affairs, this role will focus primarily on Post-Market Advertising, Labeling and Promotion. You will partner with internal stakeholders, and provide regulatory expertise and guidance needed for compliance of promotional material. In this newly created role, you will review advertising, labeling, promotional, and other related materials to ensure compliance with applicable FDA/FTC laws, regulations, and guidance.
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
Provide regulatory guidance to marketing teams for post market materials from concept through review and approval for DTC advertising, labeling and promotional materials, while maintaining compliance with governing FDA/FTC regulations and company policies
Review labeling and promotional documents for accuracy and adherence to regulatory requirements, while ensuring a complimentary brand voice
Collaborate with marketing teams to support development of a variety of different types of consumer media, including but not limited to display advertising, radio ads, email communications, social media, press, affiliate communication, blogs, video content, retail marketing and event materials
Work collaboratively with content developers to ensure brand voice is heard throughout all communications materials
Provide guidance to marketing teams to ensure consistency and efficiency in material and ideation/development
Partner with other departments to review and approve marketing materials that target audiences such as healthcare providers, academics and the scientific community
Ensure labeling changes are reviewed and if appropriate, implemented into advertising and promotional materials
Contribute to the development and implementation of policies and procedures for review and approval of marketing and promotional materials and documents
Monitor regulations, guidance, and regulatory or legal actions from the FDA, FTC, or competitors that may influence the landscape
We hope you have
Minimum of a Bachelor's degree in life science; an advanced degree is preferred (JD, MS, PhD)
Minimum of 5-7 years previous experience in regulated industry with a strong knowledge of global regulations and their interpretation relevant to OTC/DTC advertising and promotion
Strong understanding of 21 CFR 809.10, 21 CFR 820, ISO 13485, and ISO 14971
Comprehensive understanding of relevant advertising and promotional regulations and guidances
Experience reviewing content for multiple media channels (website, radio and video scripts, banner ads, etc.)
Expert level use of Word, Excel, and PowerPoint and experience with document management systems and document sharing systems
Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation and style
Ability to prioritize and multi-task while maintaining a positive and collaborative attitude
Ability to communicate clearly and professionally, both orally and in writing
Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
Ability to effectively manage time and deliver under pressure
Flexibility to support changing assignments and priorities in an independent and reliable manner
About Us 23andMe, Inc. is the leading personal genetics company. Our mission is to help people access, understand and benefit from the human genome. 23andMe has over 2 million customers worldwide with ~85 percent consented to participate in research. 23andMe is located in Mountain View, CA. More information is available at www.23andMe.com.
At 23andMe we value a diverse, inclusive work force 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. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
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.
Our mission is to help people access, understand and benefit from the human genome. 23andMe has over 1 million customers worldwide... with over 80 percent consented to participate in research. 23andMe, Inc. is located in Mountain View, CA. More information is available at www.23andMe.com.
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