Director, Regulatory Affairs Strategy Lazio

Director, Regulatory Affairs Strategy
Roma
Lazio, Lazio

A request:

For this role it is essential to speak both Italian and English.

However, as English is our internal business language, we ask that all CVs / resumes are submitted in English.

If a CV is not submitted in English, it will not be considered.

Thank you!

**Una richiesta:

Per questo ruolo essenziale parlare sia italiano che inglese.

Tuttavia, poich l'inglese la nostra lingua commerciale interna, chiediamo che tutti i CV / curriculum siano presentati in inglese.

Se un CV non presentato in inglese, non sar preso in considerazione.

Grazie!

*The Role:

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 MHRAWork 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 territoryIdentify and assess regulatory risks for assigned projects or programsContact relevant regulatory agencies relevant to assigned projects or programs, as appropriateAbility to work both independently and within project teams, committees, etc.

to achieve business goals and objectivesPrepare and deliver effective communications and presentations for external and internal audiencesSupport 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.

)Heres What Youll 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 strategyStrong knowledge of current local (Italy, Cyprus, Greece), EU and International regulations related to the clinical, nonclinical, and regulatory requirements for innovative medicinesStrong experience with eCTD and content regulatory filingsKnowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countriesCreates 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 supplementsAbility to work independently to manage multiple projects in a fast-paced environmentAbility to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each programs critical regulatory milestonesEffectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management, as relevantOutstanding 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 affiliates business activities. Fluency in English. A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and CollaborativeAbout ModernaIn 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.

Most recently, Modernas capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic. Modernas mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.

Moderna has been named a top biopharmaceutical employer by Science for the past seven years.

To learn more, visit. Moderna is a smoke-free, alcohol-free and drug-free work environment. #LI-AS5

- Full time