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Director, Regional Regulatory Strategist
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**The Role**:
The Director, Regional Regulatory Strategist - ID will have the opportunity to lead the regulatory strategy with the European Medicines Agency (EMA), act as the regulatory strategy partner for International countries, and provide regulatory support to the VP, Regulatory Affairs
- International. This is a new 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 EMA and other International agencies for messenger RNA therapeutics as a new drug modality.
**Here's What You’ll Do**:
Act as the EMA primary contact point for the assigned program
Develop and contribute to content and format for regulatory submissions and related supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, 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
Coordinate 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
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 EU and International regulations related to the clinical, and nonclinical 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
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
Ability to work both independently and within or leading project teams, committees, etc. to achieve business goals and objectives in a fast-paced environment
Ability to effectively collaborate effectively in a dynamic, cross-functional, matrixed 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 European languages is a plus.
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 year-end shutdown
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 is a smoke-free, alcohol-free and drug-free work environment.
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