Sanofi Group (Sr. Director) Disease Area Head - Rare Disease and Gene Therapy in Framingham, Massachusetts
The Disease Area Head will be leading Rare Disease and Gene Therapy within the Rare Disease/Rare Blood Disease Global Regulatory Affairs (GRA) team. In this capacity, the Disease Area Head will be overseeing the regulatory strategies of a number of projects in development as well as marketed products that still have development activities ongoing and lead a team of Global Regulatory Team Leads (GRTLs).
Development and review of regulatory strategies and regulatory “deep-dives” for individual indications in Rare Disease and Gene Therapy.
Oversee preparation of regulatory presentations for internal governance meetings.
Regulatory representative on due diligence activities for external Rare Disease and Gene Therapy development candidates.
As a member of the GRA global management team, be a driver and contributor to regulatory initiatives to improve strategic capabilities and operational excellence.
Exemplify the core values and guiding principles of GRA.
Coach and mentor GRTLs in their roles on global project teams and as leader of the global regulatory team.
Establish a network of internal stakeholders and develop a close working relationship to ensure that GRA is recognized as a valued strategic partner in the development and commercialization of products.
Have an understanding of the competitive environment of the various Rare Disease and Gene Therapy indications and support GRTLs in developing products that are differentiated and provide commercial value as well as value for the patient.
As needed, function as GRTL being the direct responsible for one of the products under responsibility.
Impact on the Organization
A robust global regulatory strategy for the Rare Disease and Gene Therapy whether for projects on the market (Commercial) or those in development, is critical for the success of the business and for the company to meet its goals.
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA).
Ability to motivate and lead others.
Team player, ability to work well within cross-functional teams and in a multicultural/multinational environment.
Excellent oral communication and writing skills.
Change management/ change enabler: embraces the challenges of a fast-changing environment.
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values.
Degree in Life Sciences.
Advanced degree is preferred (MS/PhD/PharmD/MD).
10-15 years industry experience, with at least 10 years working in regulatory affairs (regionally or globally).
Management experience of a small team is preferred.
Delivery of a number of major applications (NDA/BLA/MAA/JNDA etc.).
Experience with early/late stage development projects is required and experience with marketed products is preferred.
Prior experience in Rare Disease and/or Gene Therapy is preferred.
Languages : English
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.