Job Title: GRA CMC Project Lead

Location: Morristown, NJ Framingham, MA

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 Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The team responsibilities include but are not limited to global regulatory CMC strategies, submission dossiers and approvals, direct contact/liaison with FDA/EMA and other Regulatory Agencies as required for new and marketed chemical entities. The team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others. The team demonstrates behaviours that live and promote the Sanofi Take the Lead behaviours and GRA Values/Principles/Competencies.

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:

• Responsible for the coordination of multiple biologics projects and mentoring of GRA CMC Leads and GRA CMC Associates across teams.

• Provide leadership, guidance, and coordination to project teams of GRA CMC professionals in delivering specific development and marketed product objectives.

• Provide leadership, regulatory expertise, regulatory strategy, and regulatory influence on projects and teams.

• Accountable for strategic project management of multiple projects of varying priority & complexity, issue resolution, and decision making.

• Participate on or strategically lead multifunctional teams.

• Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, and/or vaccine products) in collaboration with other parts of GRA.

• Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated, and mitigated as necessary.

• Assures effective involvement with change control systems.

• Manages or directly contributes to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with R&D Functions, Manufacturing & Supply Functions and GRA Regulatory Operations.  Assures that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved. 

• Assures that technical and regulatory CMC issues are appropriately resolved with optimal solutions, including responses to Health Authority Questions. 

• Assures that appropriate contacts with Health Authorities, in collaboration with Country Regulatory Groups, are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships.

• Responsible for direct contact/liaison with US FDA and EMA on specific CMC topics.

• Supports strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).

• Interpret global regulations & appropriately apply, implement, and communicate regulation, established or draft guidance's.Identify/recommend changes in regulations to strengthen company business approaches.  

• Contributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized. 

• Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers. 

• Assures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated.  

• Identify regulatory opportunity and risk. Anticipate and communicate possible regulatory paradigm shifts that impact the company.

•  Identify, communicate, and manage resolution to regulatory CMC issues. Articulate the implication of issue to project team risk/benefit strategic component, ensuring consistency in approach.

•  Build and maintain internal and external relationships, managing differing priorities and objectives to achieve the implementation of appropriate regulatory strategies and outcomes. 

• As applicable, support the regulatory inspection process for development projects and marketed products.

About You

Experience:

• 10+ years pharmaceutical or related experience; prefer multidiscipline (direct Regulatory CMC experience preferred)

• 8+ years of CMC regulatory strategy, in biologics (preferred)

• Working for a Regulatory Health Authority is helpful but not essential.

• Management experience preferred

Soft skills:

• Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies.  

• Dynamic personality, ability to think outside the box.  

• Demonstrates excellent communication and influencing skills internally and externally

• Strong interpersonal skills and the ability to deal effectively with a variety of business areas including medical, scientific, and manufacturing.  

• Demonstrate strong organizational skills, including the ability to prioritize workload and capacity to work under pressure. 

Technical skills:

• Technical/pharmaceutical CMC experience (laboratory, manufacturing, etc.) is required.

• Understanding of Artificial Intelligence and impact on industry

• Strong background in drug development, manufacture, or testing

• Experience with combination (drug / device) products

• Proficient in MS Word, Excel, PowerPoint, Veeva Vault (preferred)

Education:

• B.A./B.S. degree in a scientific discipline

• Advanced degree (Masters, PhD) in a science or health field is desirable.

Languages:

• Fluent in English both spoken and written

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 safe 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.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.