Regulatory Strategist

RA, Clinical Development drugs/biologics, Veeva vault, Project Management

Job

"" >CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Sanofi we are searching for a Regulatory Strategist.

Keywords
  • RA
  • Clinical Development drugs/biologics
  • Veeva vault
  • Project Management

As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage 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 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.

Current ongoing activities:
  • CTA preparation under new CTR;
  • CTA transitions to new CTR;
  • CTA substantial amendments;
  • BB preparation for Scientific Advice;
  • PIP/PIP Waiver development.
General responsibilities:
  • Provide quality regulatory input to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects;
  • Liaise with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes;
  • Contribute to the development of a harmonised, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL Contribute to the GRT for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the target product profile (TPP), business planning, governance, and committee;
  • 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;
  • Identify regulatory risks and propose mitigations in collaboration with the GRL, to cross-functional teams working with Sanofi standardised methodologies as appropriate;
  • Contribute to the development of Global Regulatory Project Strategy (GRPS) and ensure alignment with the core product labelling for products in development as well as for life cycle management of products;
  • Participate 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;
  • Attend HA meetings and collaborate with the regions / GRACMC /GRA-Devices to communicate the outcome to senior management as needed;
  • May lead Health Authority meetings and preparations, as designated
  • Lead 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;
  • Lead 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;
  • Contribute to content and review 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;
  • Support operational and compliance activities for assigned deliverables, develop, execute 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.

Profile

The ideal candidate has a B.Sc. or M.Sc. with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience, or an advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience. Additionally, you have the following skills/knowledge:
  • Proactive;
  • Understanding of clinical development of drugs and/or novel biologics products;
  • 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.

Benefits

Maternity leave substitution till August 2024

Company profile

Sanofi is a global biopharmaceutical company focused on human health. They prevent disease through vaccines and provide innovative treatments to fight pain and relieve suffering. They help people dealing with rare diseases as well as millions of people with long-term, chronic conditions. In more than 100 countries, including the Netherlands!
Their activities in the Netherlands consist of development, registration, sales and distribution of medicines. They also offer resources for diagnosing, services and innovative care concepts.

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2300077)
Location Amsterdam
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Regulatory Strategist

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