Sanofi Group Global CHC Regulatory Allergy Lead in United States

The Sanofi Global CHC Regulatory Allergy Lead (GRL) leads the regulatory strategy and selected operational regulatory activities for the Core Global and multi-regional brands of the Global Allergy category.

The Allergy category is one of the Growth pillars of Sanofi CHC business unit requiring the GRL to take an active role in the development of the project strategies and execution plans to achieve the business goals.

This position is at the Global company level, to support Global business category in its portfolio development activities.

As the US represents one of the biggest market of this category, it is expected that the individual has a strong experience in the application of US regulations, with expertise on development requirements, and collaborative FDA consultations.

The GRL closely works with Region North America (NA) and local US regulatory experts to define the best in class development and submission strategy to meet commercial goals.

The GRL works with Global Regulatory Affairs CMC and Labelling Category teams to ensure that all regulatory requirements are addressed.

The GRL jointly with NA regulatory team prepares briefing packages and attends FDA meetings to validate the proposed strategies for development projects.

The GRL analyzes the regulatory competitive landscape to be able to propose timely and impactful regulatory strategies.

The GRL tracks any regulatory and environmental information that might have an impact on existing portfolio or development projects, and informs business with the risk assessment and mitigation proposals.

The GRL closely collaborates with the other team members of the Global Regulatory Cough & Cold and Allergy category working on Allergy portfolio, in order to ensure the development of robust programs for global projects including the non-US requirements for the innovation projects.

The GRL attends the cross-functional Project team meeting on all Global development projects, and represents the consolidated regulatory position. The individual ensures the consolidated regulatory voice, and organizes regulatory sub-teams with this purpose.

The GRL coordinates the preparation of Core-documents for the Regions/countries who complete the submission dossier and monitor the submissions, including clinical trials applications. The GRL is also responsible for the coordination of the preparation of the response Core document to answer Health authorities questions. For these tasks the GRL closely works with the regions/countries.

The GRL reviews Global communication programs and advertising campaigns.

The GRL also ensures maintenance activities for the Allergy portfolio, such as contribution to the preparation of the Core-documents required for variations, benefit/risk assessments, referrals, renewals (Addendum Clinical Overviews, PBRERs, DSURs).

The GRL contributes to the due diligences of new licensing-in and out opportunities.

The GRL works in compliance with Sanofi Quality Documents (QDs)

Competencies:

Leadership:

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 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.

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

Qualifications

  • Minimum MS; Pharm D, MD, PhD or equivalent preferred

  • Regulatory Certification (RAC) preferred

  • Minimum 10 years in Regulatory Affairs, including leadership roles and CHC environment

  • Fluent English required; additional languages desirable.

  • Recognized expert in managing matrix teams and partnering with cross functional teams at a highly strategic level.

#LI-SA

Sanofi US Services, 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.

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.

Sanofi, Empowering Life

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.

Sanofi, Empowering Life