Global CHC Regulatory Allergy Claims Lead
Bridgewater, New Jersey
The Sanofi Global CHC Global Regulatory Therapeutic Claims Lead (GRT-CL) is the champion of the regulatory strategy aimed to extend communication of the Global and Core local brands. The Lead will also execute selected operational regulatory activities that will drive the global business. This position is at the Global company level, to support the Global business category in its portfolio development activities.
- The GRT-CL is a strong business partner, understanding the category positioning and needs, and being proactive in proposing innovative approaches to drive its ambition. The individual takes an active role in the development of the business of the category.
- The GRT-CL will lead the development of regulatory strategies for the development of new claims and benefits, including the development of new products (e.g. new pharmaceutical forms) to extend communication (e.g. faster onset of action, etc.).
- The GRT-CL closely works with category key countries and/or Regions to define the best in class development and submission strategy to meet commercial goals.
- The GRT-CL jointly with Region/countries regulatory teams prepares briefing packages and attends Health authorities meetings to validate the proposed strategies and support the category ambition.
- The GRT-CL is an active member of the cross-functional Project team meeting on all Global projects and represents the consolidated regulatory position. The individual ensures the consolidated regulatory voice and organizes regulatory sub-teams with this purpose.
- The GRT-CL coordinates the preparation of Core dossiers for the Regions/countries. The GRT-CL is also responsible for the coordination of the preparation of the response Core documents to answer Health authorities questions.
- The GRT-CL keeps up-to-date with the regulatory trends and analyzes the regulatory competitive landscape to be able to propose timely and impactful regulatory strategies. The individual monitors the competitive environment to identify opportunities to be proposed to our business partner. To do so he/she relies on key countries and regions and supports the organization of local events (e.g. Claims treasure hunts).
- The individual reconciles the business ambition with the local opportunities and contributes to the roll-out of the new claims, also monitoring its implementation.
- The GRT-CL reviews Global communication programs and advertising campaigns.
- The GRT-L works in compliance with Sanofi Quality Documents (QDs).
Inspiring professional who will leverage his/her regulatory experience and commercial awareness to proactively contribute to CHC business growth.
Strategic & Technical Regulatory Affairs Expertise:
Demonstrated success in developing regulatory strategies in OTC environments; possesses a strong knowledge of the regulatory requirements. He/she will bring creative & innovative ideas to the table to support pragmatic and/or innovative approaches and enable category strategies
Communication & Influencing:
The successful candidate will possess strong communication, negotiation and influencing skills. He/she will be at ease working in a matrix environment and display the necessary multicultural sensitivity in such a Global context.
- Lead teams
- Think Strategically
- Cooperate Transversally
- Act for Change
- Strive for Results
- Commitment to Customer
- Develop people
Other Personal Characteristics:
- High standards of integrity
- Strong interpersonal skills
- Excellent oral and written presentation skills
- Dedicated and persuasive “can-do” attitude
- Self-motivated; entrepreneurial spirit; excellent time management skills
- Organizational savvy; be able to work in a highly matrix structure including sharing knowledge with relevant stakeholders
- “Think out of the box” mindset
- Minimum BS. MS, Pharm D, MD, PhD or equivalent preferred
- Regulatory Certification (RAC) preferred
- Minimum 7 years in Regulatory Affairs, including leadership roles and CHC environment
- Strong knowledge in NDA, dietary suppléments and medical devices US regulation
- Strong experience in FDA meetings
- Fluent English required; additional languages desirable.
- Recognized expert in managing matrix teams and partnering with cross functional teams at a highly strategic level.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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