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.
PRIMARY OBJECTIVES
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 be considered for an interview, please complete a fellowship application on the MCPHS SMApply application portal. Visit https://mcphs.smapply.io/
Please DO NOT request an interview within PPS. Our recruitment teams will contact qualified candidates via email to schedule interviews.
The MCPHS application portal will open up on October 2, 2023. Applicants must upload the following application materials to the online portal by November 17, 2023:
Letter of intent
Curriculum vitae
Unofficial college transcript
Contact information for three references. References will receive an electronic recommendation form to complete separately.
Incomplete applications WILL NOT be reviewed. Interviews CANNOT be scheduled until these materials have been submitted. Please keep in mind that this is a competitive process and applicants are encouraged to complete their applications as soon as possible.
Recommendations
Three recommendation evaluation forms must be submitted no later than November 27, 2023, via the online portal. This is NOT a letter of recommendation but an online form that the reference will need to complete.
Rolling Application Review & Interviews
All submitted applications will be reviewed on a rolling basis. Interviews will also be offered on a rolling basis and opportunities are limited. Priority will be given to those applicants who apply early, well in advance of the deadline.
Rolling interviews will begin mid-October with pre-screens and a mixture of interview rounds, and will conclude in December at the end of the ASHP Midyear Clinical Meeting. Candidates will be notified if selected for an interview.
ASHP Midyear & Onsite Interviews
The fellowship program will be conducting in-person interviews at the ASHP Midyear Clinical Meeting in Burbank, CA. Applicants are strongly encouraged to attend. Candidates attending in-person will not be able to interview without registering for both ASHP and PPS. Please refer to the ASHP & PPS website for registration details.
Top candidates may be invited for interviews at the sponsoring company’s location pending COVID – 19 restrictions.
Offer Dates
Recognizing that the choice of a Post-Doctoral Industry Fellowship is an important decision, MCPHS in conjunction with the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offers for Fellowships no earlier than December 13, 2023.
Onboarding
Final candidates will be required to go through additional screening / onboarding as required by MCPHS.
Eligibility
The MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis. Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy at the commencement of the program.
Candidates must have strong written and verbal communication skills and a strong interest in pursuing a career within the biopharmaceutical industry.
All candidates must have authorization to work in the United States throughout the duration of the one or two year fellowship. No visa sponsorship will be provided (i.e., TN, H-1B, STEM OPT, etc.).
Sanofi is an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Sanofi’s global specialty care business unit focuses on rare diseases, rare blood disorders, neurology, immunology, and oncology. Its approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities. Our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine for millions of people around the world.