Director, Regulatory Affairs Strategy

Moderna

Rome, Italy

The Role:

The Director of Regulatory Affairs-International based in Italy will have the opportunity to lead the regulatory strategy within the local affiliate (Italy, Cyprus, Greece).

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, Oncology, Cardiovascular and rare diseases.

Their support includes but is not limited to managing the regulatory interactions and marketing authorization applications for Italy, Cyprus, Greece. This person will work closely with the business in the country affiliate to provide the regulatory guidance to support the overall business plans. This role will also be involved with other International regulatory interactions and submissions (MHRA interactions incl. MAA submissions and life cycle; orphan drug designations, pediatric plans; DSURs; PSURs 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, PSURs, MAA etc.);
Lead the regulatory interactions with the MHRA;
Work with VP-RA International and Global Regulatory Teams regarding the development and execution of regulatory strategy in the local markets (Italy, Cyprus, Greece);
Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs for the assigned territory;
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;
Support the local business objectives and support the commercial execution from regulatory perspective (e.g. artwork review; promotional materials reviews; regulatory trainings and updates to the local affiliate business team; support to Market Access with regulatory documents needed for pricing/reimbursement/tenders etc.).

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 (Italy, Cyprus, Greece), 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 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;
Effective collaboration with to the other line functions within the local affiliate (such as general manager; commercial strategy; market access; pharmacovigilance; quality assurance etc.); proactive regulatory input and support to the local affiliate’s business activities;
Fluency in English;
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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Director, Regulatory Affairs Strategy