Regulatory Strategist - VIE Contract

Sanofi • Morristown, NJ

13d

About The Position

As Regulatory Strategist VIE within our General Medicines team, you’ll be a key member of the GRT, and strategic partner to the GRL, and will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions. You will also provide regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you’ll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve.

Requirements

• Minimum 1 year of full-time relevant experience.
• Strong interest in Regulatory Affairs.
• Proficient in the use of MS Word, PowerPoint, Excel, and collaborative work environment tools (eg. SharePoint).
• Rigor, adaptability, team spirit.
• Strong sensitivity for a multicultural/multinational environment.
• Fluency in English.
• Master’s Degree in Pharmacy, Life Science or other related field.

Nice To Haves

• Ability to work in electronic document management systems, e.g., Veeva vault is a plus.

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 Global Regulatory Team (GRT) for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the TPP, business planning, governance, and committees.
• May be requested to lead Global Regulatory Team meetings.
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed.
• Identifies regulatory risks and proposes mitigations in collaboration with the GRL, to cross-functional teams working with Sanofi standardized methodologies as appropriate.
• Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of products.
• Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations.
• Ensure that respective regulatory team members have the information necessary to contribute to the development and execution of the Global Regulatory Strategy for their responsible accountabilities.
• Accountable for developing the Health Authority engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself.
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management.
• Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit.

Benefits

• iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe.
• At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.
• Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow.
• We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries.
• Sanofi unites people who are passionate about solving healthcare needs across the world.
• Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.

What This Job Offers

• Career Level: Entry Level