Governance, Risk, Compliance Manager
Fragomen
Regulatory Strategist
Sanofi
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $122,250 - $176,583 per year
Job Level
Mid-LevelSenior
Tech Stack
Vault
About the role
- Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects
- Liaises with clinical, commercial and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
- Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL
- Proactively contribute with curiosity and openness to diverse perspectives
- Contributes to operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant
Requirements
- BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience OR Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required
- Understanding of clinical development of drugs and/or innovative biologics products
- Demonstrated experience with driving the preparation of regulatory documents (e.g. (s)BLA/(s)NDA/MAA, INDs/CTAs, Health Authority meeting briefing documents) and negotiating with a national/regional Health Authority
- Emerging business acumen, leadership, influencing and negotiation skills
- Ability to use appropriate interpersonal styles and techniques to build internal and external networks and lead discussions with internal and external stakeholders.
- Effective communication skills, specifically strong oral and written presentation skills.
- Experience working in and strong knowledge of electronic document management systems (e.g. Veeva Vault RIM, Plai).
- Demonstrated ability to manage multiple projects/deliverables simultaneously.
- Strong sensitivity for a multicultural/multinational environment.
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsregulatory documents preparationclinical developmentsubmission content planssubmission trackingdocument managementnegotiation with Health Authorityproject managementbiologics productspharmaceutical industry experience
Soft skills
leadershipinfluencingnegotiation skillsinterpersonal skillseffective communicationpresentation skillscuriosityopenness to diverse perspectivesnetwork buildingmulticultural sensitivity
Certifications
BS/BA degreeMSc in BiologyPharmDPhDMDDVM
