Regulatory Strategist, Associate Director-Vaccines
The team is involved in developing regulatory product strategies for the therapeutic area, leading regulatory efforts in the development stage and post marketing of drug products.
As a key member of the GRT, and strategic partner to the GRL, the RS 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 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.
This position is for the Pertussis Polio Hib pediatric and booster combination vaccines. The candidate is required to have agility to work transversally on combination vaccines across Canadian and French products and if required across other Therapeutic Areas within the Vaccine Global Business Unit as needed. The scope of the licensing work can include Research and Development or established product licensing.
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 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 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.
Knowledge, Skills & Competencies: (Minimum required)
Proactively contribute with curiosity and openness to diverse perspectives
Emerging understanding of clinical development of drugs and/or novel biologics products
Demonstrates business acumen, leadership, influencing and negotiation skills
Effective communication skills, specifically strong oral and written presentation skills preferred
Ability to work in electronic document management systems, e.g., Veeva vault is a plus
Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred
Strong sensitivity for a multicultural/multinational environment.
Experience & Education: (Minimum required)
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
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