MCPHS​/Sanofi –Global Reg. Affairs - CMC & Devices Sanofi- US Public Affairs & Patient Advocacy

MCPHS and Sanofi are pleased to offer numerous Post Pharm

D Fellowship positions and are currently screening and scheduling interviews.

Sanofi Biopharmaceutical Fellowships | MCPHS

This fellowship is focused on providing the fellow with the necessary skills and tools to become a knowledgeable, confident, and strategic Regulatory Affairs professional. Specifically, the Fellow will gain a thorough understanding of the regulatory functions of the Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA CMC) department and build a strong foundation in the development process from early stage to post-marketing with a focus in Biologics CMC.

In this role, the Fellow will develop the knowledge and experience to assist the team in effectively and efficiently achieving and maintaining regulatory approvals, with the end goal of delivering consistently safe, effective, and high-quality pharmaceutical products to consumers.

• Develop regulatory strategic skills while contributing to global pre- and post-approval planning and submissions potentially including:
  Briefing documents, Health Authority interactions, IND/CTA submissions, BLA/NDA/MAA applications.
• Focus on biologic products in various therapeutic areas which include but are not limited to rare diseases (many of which are orphan drugs), hematology, immunology, multiple sclerosis, oncology, and diabetes.
• Lead team meetings, develop regulatory strategy, and contribute to and lead Health Authority submissions with increasing responsibility throughout the Fellowship program.
• Gain exposure to the entire manufacturing process from development through post-marketing
• Partner with contributing functions within Sanofi to deliver products for diseases globally
• Gain an understanding of country-specific regulations by partnering and engaging with our affiliates worldwide
• Opportunity to tailor the program to your unique interests and professional development needs.

To provide the US Public Affairs and Patient Advocacy (US PA&PA) fellow with necessary hands-on experience, knowledge, and skills to make a positive impact on patient health outcomes.

The US PA&PA team partners with US patient advocacy groups and professional societies to champion issues critical to patients. Coordinating the company’s approach with external advocates requires active engagement and extensive collaboration with various internal, cross-functional teams across all parts of the company.

As an active member of the healthcare ecosystem, Sanofi is dedicated to the needs of patients and finding collaborative solutions. Our goal is to be a partner who listens, acts, and leads to improve patient health, accelerate medical innovation, and facilitate access to medicines and vaccines. US PA&PA bridges the insights, knowledge, and resources of both the external advocacy community and within Sanofi to support advocacy initiatives that matter most to patients.

During this two-year program, the fellow will:

• Build and maintain external advocacy relationships by liaising with US patient groups, medical and professional societies, health foundations, and other stakeholders in the advocacy community to inform internal decision-making and patient-centric initiatives.
• Enhance their understanding of the US healthcare system through leadership on cross-functional projects that aim to develop timely, evidence-based, patient-centric solutions.
• Develop and enhance critical skills while working with colleagues across Corporate Affairs, R&D, medical, and commercial teams to manage partnerships and projects in a global, diversified healthcare solutions company.
• Strategically network and build meaningful relationships with internal leadership and external advocacy leaders across the healthcare ecosystem.

Core experience will be within the Sanofi Specialty Care therapeutic areas (Rare Blood Disorders, Rare Diseases, Immunology, Neurology and Oncology). Additional opportunities to gain experience within Vaccines and the General Medicines (Type 1 Diabetes, Cardiometabolic and Transplant) therapeutic areas, if desired.

Outside of their experiences in US Public Affairs & Patient Advocacy, the Fellow may also have rotational or project experience(s) in other areas of the company to further enhance their professional development, including Global Public Affairs, Reimbursement & Public Policy, Science Policy, Federal and State Government Relations, Communications and Corporate Social Responsibility, and Market Access.

View the Sanofi Program Brochure for more information, or visit http://(Use the "Apply for this Job" box below). or general fellowship program information. In addition, see all of our Sanofi and other MCPHS Fellowship Program offerings here .

To be considered for an interview, please complete a fellowship application on the MCPHS SMApply application portal. Visit…