Director, Regulatory Strategy - EEMEA

Director, Regulatory Strategy - EEMEA

Moderna

Basel, Switzerland

The Role:

The Director of Regulatory Affairs- EEMEA, based in the EMEA HQ of Moderna in Basel, Switzerland will have the opportunity to lead the regulatory strategy for the assigned region and provide regulatory support to the Sr. Dir. of Regulatory Affairs, EMEA and the General Managers/Commercial Partners of Moderna’s Affiliates, if relevant.

This is a newly created role intended for a forward looking, creative and agile regulatory Director able to anticipate and address the challenges involved in supporting the interactions with the Local Competent Authorities in the respective countries, for messenger RNA therapeutics as unprecedented new drug modality. The Director will provide regulatory support across the Therapeutic Areas including Infectious Diseases. Their support includes but is not limited to managing the regulatory interactions and marketing authorization applications in Eastern Europe, Middle East and Africa. This person will work closely with the business in the region to provide the regulatory guidance to support the overall business plans including Health Technology Assessment support. This role may also be involved with other International regulatory interactions and submissions (orphan drug designations, pediatric plans, PRIME, DSURs, MAA, etc.).

Here's What You’ll Do:

  • Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including National Competent Authorities (NCAs) regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, PSURs, MAAs, post approval regulatory deliverables such as variations, line extensions etc.);
  • Work with International Regulatory team and Global Regulatory Teams on the development and execution of regulatory strategy in the assigned countries;
  • Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs either directly or via partners and consultants in the assigned region;
  • Identify and assess regulatory risks for assigned projects or programs;
  • Support the execution of the regional strategic and operational imperatives, in close collaboration with the General Managers, external partners and Commercial Leadership of the region;
  • Act as the single contact point for relevant regulatory authorities as appropriate; lead and coordinate all strategic Health Authority interactions; plan and execute meetings with the Regulatory Authorities; coordinate the cross-functional preparation and delivery of the meetings;
  • Prepare and deliver effective communications and presentations for external and internal audiences;
  • Ability to work both independently and within project teams, committees, etc. to achieve business goals and objectives.

Here’s What You’ll Bring to the Table:

  • Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD);
  • 12+ years of experience in the pharmaceutical industry; 10+ years of experience in Regulatory strategy;
  • Strong knowledge of current local and international regulations in the region related to the clinical, nonclinical, and CMC development;
  • Strong experience with CTD format and content regulatory filings;
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries;
  • Creates and maintains the regulatory dossiers including reviewing and providing input to the Information for Professionals and Patient and Packaging Information as well as National Succinct Statement per NCA approval;
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements;
  • Experience and knowledge in the preparation, review and approval of promotional materials, artworks and packaging materials;
  • Ability to work independently to manage multiple projects in a fast-paced environment;
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones;
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant;
  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Fluency in English is required. The knowledge of other languages is a plus;
  • A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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