Regulatory Affairs Manager specializing in food industry compliance across US/North America. Leading regulatory strategies and communication for food ingredients and products.
About the role
- Regulatory Strategist shaping the future of medicine by leading regulatory efforts for drug development projects. Collaborating with diverse teams to ensure successful regulatory outcomes.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Compliance Analyst participating in financial compliance processes at Prex. Utilizing data analysis for risk identification and maintaining regulatory compliance.
Control, Risk and Compliance Analyst at Desjardins managing compliance for savings and investment products. Preparing reports and liaising with stakeholders to ensure regulatory compliance and operational risk management.
Senior Manager leading technology - enabled GRC solutions and guiding compliance frameworks. Collaborates with teams to ensure scalable and practical implementations for Crowe's regulatory practices.
Alternant en conformité réglementaire chez Sanofi, contribuant à la conformité mondiale des activités de santé. Collaborant avec une équipe pour développer compétences tout en soutenant l'avenir de la santé.
Environmental Professional ensuring air compliance and permit management for oil and gas operations. Collaborating with teams on compliance, reporting, and regulatory issues across various states.
Senior Audit & Compliance Specialist developing audit schedules and conducting audits in insurance sectors. Collaborating with teams to drive quality improvements across claims procedures and training.
Senior Manager overseeing quality compliance and implementation of Quality Systems in external manufacturing. Supporting compliance with regulatory standards across Global External Manufacturing network at Bristol Myers Squibb.
Analyst supporting energy efficiency programs at Eversource. Reporting operations, regulatory support, and portfolio forecasting for clean energy initiatives in Massachusetts.
Technology Compliance Officer at Specsavers ensuring regulatory compliance across Northern Europe. Guiding product teams in understanding obligations while building compliance into design and process.