*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:
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.
Here's What Youll 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.
)
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 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 programs 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 affiliates business activities.
Fluency in English.
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary winter break
Educational resources
Savings and investments
Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
In over 10 years since its inception, Moderna has transformed from a 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 seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.
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, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's 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 autoimmune diseases.
Moderna has been named a top biopharmaceutical employer by Science for the past seven years.
To learn more, visit (url removed).
Moderna is a smoke-free, alcohol-free and drug-free work environment.
LI-NS1