Director, Regulatory Affairs Strategy

Director, Regulatory Affairs Strategy

Moderna

Spain or Netherlands

The Role:

The Director of Regulatory Affairs-International based in either Spain, or the Netherlands will have the opportunity to lead the regulatory strategy within the local affiliate (Spain or Netherlands), as well as an assigned International Regulatory Strategy Project (e.g. WHO pre-qualification process, or responsibility for overseas internal markets/regions..

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 regulatory authorities for the assigned region/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 for Europe, Asia, Africa. This person will work closely with the business in the country affiliate (Spain or Netherlands) to provide the regulatory guidance to support the overall business plans. This role will also be involved with other International regulatory interactions and submissions (such as WHO pre-qualification procedure, responsibility for Regulatory interactions in Asia/Africa etc. with the help of local partner companies; 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, regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, MAA etc.;
  • Work with VP-RA International and Global Regulatory Teams regarding the development and execution of regulatory strategy in the EU and International countries (possibly Latin America);
  • Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs;
  • Identify and assess regulatory risks for assigned projects or programs;
  • Contact relevant regulatory agencies relevant to assigned projects or programs, as appropriate;
  • Ability to work both independently and within project teams, committees, etc. to achieve business goals and objectives;
  • Prepare and deliver effective communications and presentations for external and internal audiences.

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

  • Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD);
  • 10+ years of experience in the Pharmaceutical industry. 7+ years of experience in Regulatory strategy;
  • Strong knowledge of current local (Spain or Netherlands), EU and International regulations related to the clinical, nonclinical, and regulatory requirements for innovative medicines;
  • Strong experience with eCTD 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 local/EU/International parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information as well as National Succinct Statement;
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements;
  • 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 and the local affiliate language (Spanish or Dutch, respectively) is required. The knowledge of other European 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 2021

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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