What are the responsibilities and job description for the Director, Global Regulatory Affairs - Global Labeling Strategy position at Lensa?
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Job Title: Director, Global Regulatory Affairs – Global Labeling Strategy
Location : Morristown, NJ or Cambridge, MA (Hybrid)
About The Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists.
The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3 protocols, recommendation for the selection of endpoints relevant for labeling, and consideration of patient experience data (e.g., Patient Report Outcomes, quality of life measures). This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the Sanofi “Label as a driver” philosophy.
The Director ensures that core labeling (e.g., Company Core Data Sheets) and regional labeling (e.g., US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Sanofi products. The role is accountable for the quality and consistency of labeling content across global markets and supports interactions with regulatory authorities during labeling development and negotiation.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities
COMPETENCES
#GD-SA
#vhd
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The Salary Range For This Position Is
$172,500.00 - $249,166.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
If you have questions about this posting, please contact support@lensa.com
Job Title: Director, Global Regulatory Affairs – Global Labeling Strategy
Location : Morristown, NJ or Cambridge, MA (Hybrid)
About The Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists.
The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3 protocols, recommendation for the selection of endpoints relevant for labeling, and consideration of patient experience data (e.g., Patient Report Outcomes, quality of life measures). This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the Sanofi “Label as a driver” philosophy.
The Director ensures that core labeling (e.g., Company Core Data Sheets) and regional labeling (e.g., US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Sanofi products. The role is accountable for the quality and consistency of labeling content across global markets and supports interactions with regulatory authorities during labeling development and negotiation.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities
- Lead the development, maintenance, and alignment of global labeling strategy and content (e.g., CCDS, USPI, SmPC) for assigned products throughout the product lifecycle.
- Provide regulatory labeling leadership to cross-functional teams (Regulatory Strategy, Clinical Development, Medical Affairs, Pharmacovigilance, Market Access…).
- Contribute to early development programs by identifying labeling-relevant clinical endpoints, offering strategic input into the design of Phase 2 and Phase 3 clinical trials.
- Assess opportunities for the integration of patient experience data (e.g., PROs, QoL measures) to support future labeling claims.
- Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and decision-making.
- Coordinate end-to-end labeling processes, including governance review, internal alignment, and submission planning for regulatory dossiers.
- Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions.
- Ensure consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues.
- Monitor external regulatory environment, competitor labeling trends, and emerging guidance to inform strategic labeling decisions, and partner with GRA policy teams to connect the evolution in the environment with the labelling strategy
- May lead or participate in process improvement, digital transformation, or operational excellence initiatives within Global Labeling and transversally across GRA/Sanofi as applicable.
- Mentor and guide junior team members; may directly supervise Global Labeling Strategists depending on organizational structure.
COMPETENCES
- Strong knowledge of global regulatory labeling requirements (FDA, EMA, ICH) and lifecycle labeling best practices.
- Strategic thinking with the ability to anticipate and influence regulatory direction across the development continuum.
- Scientific rigor and analytical ability to interpret complex data and develop regulatory-sound labeling content.
- Proven leadership and collaboration skills in cross-functional, matrixed environments.
- Excellent communication, negotiation, and stakeholder management skills.
- Project and time management expertise; able to manage multiple priorities in parallel.
- Strong understanding of regulatory submission processes and health authority interactions.
- Advanced degree (PharmD, PhD, MD, or MSc) in life sciences, pharmacy, or a medically related field.
- Minimum 10 years of experience in the pharmaceutical or biotechnology industry, including 5-6 years in regulatory affairs with significant experience in labeling strategy.
- Experience with investigational and marketed products across multiple regions (US, EU required).
- Proven involvement in early development labeling strategy, including contributions to clinical protocol development and endpoint discussions.
- Experience incorporating patient-focused evidence into labeling strategy is a plus.
- Prior experience managing or mentoring team members is preferred.
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
#GD-SA
#vhd
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The Salary Range For This Position Is
$172,500.00 - $249,166.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
If you have questions about this posting, please contact support@lensa.com
Salary : $172,500 - $249,167