GRA CMC Lead
Sanofi US, Convent Station, NJ, United States
Overview
Job title:
GRA CMC Lead
Location:
Morristown, NJ
As a GRA CMC Lead within our GRA Regulatory CMC & Devices (Vaccines) you’ll be responsible for managing a portfolio of projects and/or marketed products. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
Within the “GRA Regulatory CMC & Devices (Vaccines)” department, the GRA CMC Lead, Vaccines is responsible for the global CMC regulatory strategy definition, managing variation approvals and questions as well as direct interactions with Health Authorities.
Responsibilities
Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities.
Participate in Change Control assessment.
Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies.
Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account.
Ensure that requests from Health Authorities are taken into account in an effective and timely manner. Develop lasting relationships with the Health Authorities.
Provide the necessary support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe), to take pragmatic decisions with the greatest probability of success.
Draft or contribute to the drafting, preparation, review and approval of supporting documents for consultation with health authorities in order to define the future submission strategy; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs.
Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs. To ensure the monitoring and management of post-approval commitments in connection with CMC activities.
Ensure that variation files are prepared in accordance with requirements, quality standards and within the time allotted.
Author the CMC strategy document “Global Regulatory CMC Strategy Document” in connection with the Blue Print model if applicable.
Ensure that CMC regulatory issues are considered and resolved optimally.
If applicable, support the regulatory inspection process.
Contribute to Sanofi initiatives, review of local and international regulations and guidelines. Ensure that the requirements of the Health Authorities are taken into account and communicated.
About You Experience
At least 4+ years' experience in a regulatory role
Operational experience within an organization (medium to large) in Regulatory CMC department
Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations. Ability to solve strategic technical and regulatory problems.
Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners.
Education
BS/BA degree in a relevant scientific discipline required.
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred.
Why Choose Us?
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; 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.
The salary range for this position is:
$122,250.00 - $176,583.33
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.
US and Puerto Rico Residents Only
North America Applicants Only
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GRA CMC Lead
Location:
Morristown, NJ
As a GRA CMC Lead within our GRA Regulatory CMC & Devices (Vaccines) you’ll be responsible for managing a portfolio of projects and/or marketed products. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
Within the “GRA Regulatory CMC & Devices (Vaccines)” department, the GRA CMC Lead, Vaccines is responsible for the global CMC regulatory strategy definition, managing variation approvals and questions as well as direct interactions with Health Authorities.
Responsibilities
Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities.
Participate in Change Control assessment.
Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies.
Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account.
Ensure that requests from Health Authorities are taken into account in an effective and timely manner. Develop lasting relationships with the Health Authorities.
Provide the necessary support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe), to take pragmatic decisions with the greatest probability of success.
Draft or contribute to the drafting, preparation, review and approval of supporting documents for consultation with health authorities in order to define the future submission strategy; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs.
Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs. To ensure the monitoring and management of post-approval commitments in connection with CMC activities.
Ensure that variation files are prepared in accordance with requirements, quality standards and within the time allotted.
Author the CMC strategy document “Global Regulatory CMC Strategy Document” in connection with the Blue Print model if applicable.
Ensure that CMC regulatory issues are considered and resolved optimally.
If applicable, support the regulatory inspection process.
Contribute to Sanofi initiatives, review of local and international regulations and guidelines. Ensure that the requirements of the Health Authorities are taken into account and communicated.
About You Experience
At least 4+ years' experience in a regulatory role
Operational experience within an organization (medium to large) in Regulatory CMC department
Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations. Ability to solve strategic technical and regulatory problems.
Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners.
Education
BS/BA degree in a relevant scientific discipline required.
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred.
Why Choose Us?
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; 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.
The salary range for this position is:
$122,250.00 - $176,583.33
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.
US and Puerto Rico Residents Only
North America Applicants Only
#J-18808-Ljbffr