Location
Bridgewater, NJ | United States
Job description
The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages and post marketing to support the Diabetes Franchise business, driving the growth of the General Medicines Global Business Unit. In our team, as US lead, you will be the point of contact with the FDA. You will lead the US regulatory strategy and the interactions with the FDA You will also have the opportunity to expand your expertise to other markets outside of US.
TZIELD is disease-modifying treatment, a first-in-class therapy in Autoimmune Diabetes (Type 1 Diabetes).
Our newest core asset aims at delaying the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years of age older. This means that for the first time, people at risk of developing this lifelong disease have fresh hope. What delayed onset means is more time for children to be children with less healthcare and more care-free childhood. The delay also gives families and healthcare professionals more time to prepare care plans for a later diagnosis.
Leads the US regulatory strategy and the interactions with the FDA.
As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Senior Regulatory Strategist leverages their 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.
The Senior Regulatory Strategist provides 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.
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
Contributes to the 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 represent GRT strategic position on behalf of the GRL at regulatory forums/committees at request of GRL
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
May contribute to the development of global HA interaction strategy in collaboration with non-US – non-EU regions / GRA-CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed
May lead Health Authority meetings and preparations as designated
Leads submission team or regulatory sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier / collaborates with regional lead where region-specific submissions are applicable
Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation
Ensure that regulatory messaging for regulatory submission documents is aligned with program level and company objectives
Contributes to content and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc.)
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.
BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred
Significant US regulatory expertise required, direct interaction/negotiation with FDA
At least 8 years of prior pharmaceutical/biotechnology industry experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase
Demonstrated experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority preferred. Experience on multidisciplinary matrixed project teams (e.g. clinical study team)Project leadership experience preferred
Proactively contribute with curiosity and openness to diverse perspectives
Advanced understanding of clinical development of drugs and/or innovative biologics products
Demonstrated significant leadership 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
Demonstrates business acumen, leadership, influencing and negotiation skills
Demonstrated ability to use appropriate interpersonal styles and techniques to build internal networks and lead negotiations with internal and external stakeholders
Highly effective communication skills, specifically strong oral and written presentation skills
Excellent time-management and operational skills including planning and organizing
Demonstrated experience working in and strong knowledge of electronic document management systems to obtain and leverage regulatory deliverables (e.g. Veeva vault, Plai)
Demonstrated ability to handle multiple projects/deliverables simultaneously
Self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders
Understanding of the therapeutic area marketplace and drug development
Strong sensitivity for a multicultural/multinational environment.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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