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Sanofi Group Vice President, Therapeutic Area Head, Global Regulatory Affairs – Specialty Care in Cambridge, Massachusetts

Sanofi's CEO, Paul Hudson, is focused on gearing the company towards high growth areas. In December 2019, the company announced ending its research efforts in diabetes and cardiovascular diseases as part of a revamp, which included reducing the number of its core, global business units from the existing five to three focused on Specialty Care, Vaccines and General Medicines.

The company is guided by a core purpose: serve life not only for consumers and customers, but also for health care professionals, employees, and partners.

Furthermore, Sanofi has identified four key tenets: Courage (Dare to risk), Respect (Embrace and value differences), Teamwork (Grow and win together), and Integrity (Ethics before profit). This purpose guides the company’s business dynamic and empowers its strategic ambition to be the best consumer healthcare player with a sustainable growth model, strong focus towards innovation, enabling the division to continue performing above market.

Sanofi Genzyme is the Specialty Care global business unit of Sanofi, focused on rare diseases, rare blood disorders, neurology, immunology, and oncology. It helps people with debilitating and complex conditions that are often difficult to diagnose and treat, and is dedicated to discovering and advancing new therapies, providing hope to patients and their families worldwide.

The major products of the business unit include Aldurazyme®, Aubagio®, Caprelsa® tablets, Alprolix®, Cablivi®, Eloctate®, Lumizyme®, Libtayo®, Cerdelga® capsules, Cerezyme®, Clolar®, Dupixent® injection, Elitek®, Eloxatin®, Fabrazyme®, Jevtana®, Kevzara® injection, Lemtrada®, Sarclisa®, Taxotere® injection concentrate, and Zaltrap® injection for intravenous infusion. The company also addresses the unmet needs in immune diseases including atopic dermatitis, rheumatoid arthritis, asthma, nasal polyposis, and eosinophilic esophagitis.

The company’s ambition is to be the industry leader in specialty care. Its approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities.

The Therapeutic Area (TA) Head, Global Regulatory Affairs - Specialty Care will be responsible for providing management and leadership to a group of Global Regulatory Leaders (GRLs) in the development and implementation of regulatory strategies to gain product approval and compliant maintenance worldwide within the Therapeutic Area portfolio. This role could be responsible products covering several modalities including small molecule, biologics, gene therapies, devices and nanobody technology.

Some of the main benefits of this role include flexible remote working options, competitive salary, annual individual bonus for your contribution to the Company’s business and success, generous holidays and special leaves to enjoy your personal family life and range of services and resources to help you stay in a good health and live your life to its fullest.

Some specific elements of the role include:

  • Team Supervision and Leadership - Provide Leadership to the Therapeutic Area and is accountable for TA organizational design, people development (supervising, coaching, mentoring), resource allocation (recruitment, retention, talent development, succession planning etc.), metrics, and budgeting

  • Oversees the development and ultimately accountable for the Global Regulatory strategies for development and marketed products in the Therapeutic Areas portfolio. This includes the preparation and review and approval of relevant documentation for Regulatory submissions as appropriate

  • Works as a member of the GRA Specialty Care Leadership Team on people management, business unit effectiveness, budget, and other related regulatory function related business activities

  • Provide relevant input to Global Regulatory Product Strategy (GRPS) and ensure preparation of the GRLs for the Transversal Product Strategic Committee reviews (TPSC) preparations

  • Develop and maintain a close working relationship with all the regional TA regulatory leaders; leverage their skills and capabilities and ensure coordination and alignment of regional regulatory strategies and execution with the global regulatory project teams, including agency discussions for projects as needed

  • Ensure that Executive Leadership Team is aware of any major issues with projects, including any changes to risks, so that the appropriate message is communicated with a single regulatory voice to any key project governance milestone committee(s)

  • Align the regulatory affairs function in line management while ensuring senior executives have strong connections with the P&L business unit

  • Work with the TA labeling strategy leads to ensure labeling discussions occur as early in development as possible

  • Provide Leadership to the global regulatory TA GRL team and provide coaching and mentoring; foster an environment and culture of learning and sharing of best practices within the TA, and across other TA GRA units

  • Work in close collaboration with the other TA heads within the Specialty Care Business Unit

Business Support:

  • Represent GRA as a member of the Therapeutic Area Review Committee (TARC), a group led by the Therapeutic Area Development Head and Commercial Head, and be accountable for providing regulatory input for the projects globally

  • May participate in any relevant Business Unit New Product Planning (NPP) review when called upon by the Global Business Unit

  • May be asked to participate in Due Diligence and as needed, to provide regulatory input on potential new in-licensing opportunities

  • May be asked to join portfolio review to provide relevant regulatory input to the business

  • May be asked to represent GRA in Products Alert teams or Crisis teams related to the product portfolio

  • Contribute to Regulatory priorities, budget, vision, quality, and continuous improvement

Professional Experience/Qualifications:

  • The Therapeutic Area (TA) Head, Global Regulatory Affairs - Specialty Care will be a highly talented, scientifically driven leader with relevant experience in all the key areas of cutting regulatory strategy. Candidates should bring years of progressive experience in successfully managing Regulatory strategy groups.

  • Bachelor's degree in scientific field required. Ph.D., Pharm.D or M.D. degree preferred.

  • 10-15 years of pharmaceutical/biotechnology industry experience, which shall include 10 years of Regulatory experience (regional or global) and worldwide experience of regulatory submissions and approvals.

  • Experience with international regulatory submissions/maintenance (e.g., NDA/BLA/MAA/JNDA submissions and approvals) and an understanding of worldwide drug and biologics guidelines and regulations

  • Experience in other relevant functions will be considered.

  • Willingness and ability to travel

  • Excellent communication and organizational skills required

  • The individual will have the following key strengths:

  • Demonstrated people management experience, including hiring, development/growth and retention of talented personnel, differentiating performance and rewarding accordingly in a highly competitive environment

  • Experience in leading regulatory agency meetings resulting in successful regulatory approvals, including product defense experience for products marketed globally

  • Excellent oral and written communication skills - invaluable in communicating with global, cross-functional, cross-cultural, multi-disciplinary project teams including team members in country offices. Experienced in communicating vertically and horizontally within an organization and with necessary cultural awareness and sensitivity

  • Respectful, collaborative team player with both line and matrix management experience

  • Ability to rapidly understand & analyze complex problems/situations; active participation & management of projects leading to solution development & implementation, including an understanding of RWE, novel clinical trial designs, patient focused drug development, and cloud-based technologies

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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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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