Manager, Regional Regulatory Strategy

vor 3 Wochen

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in supporting the Health Agency interactions in EU and International markets for messenger RNA therapeutics as unprecedented new drug modality.

**Here's What You’ll Do**:
Work with the Sr Director Regulatory Strategy, the Project team, the RA International team, the International Reg-CMC, and Global Regulatory Sub-Teams regarding the development and execution of regulatory strategy in the EU and International countries in collaboration with the Country Leads

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 group goals

Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from International Health Agencies

**Here’s What You’ll Bring to the Table**:
Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)

5+ years of experience in the pharmaceutical industry. 3+ years of experience in Regulatory strategy

Strong knowledge of current EU and International regulations related to the clinical, nonclinical, and CMC 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 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

Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned

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.

LI-DNI

  • Manager, Regional Regulatory Strategy- Oncology

    vor 2 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Director, Regulatory Affairs-Regional Regulatory Strategist, - EU & International. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and...

  • Manager, Regional Regulatory Strategy

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    The Role:The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges...

  • Director, Regional Regulatory Strategy, Infectious

    vor 2 Wochen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Manager, Regulatory Strategy

    Vor 5 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    The Role:The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges...

  • Director, Regional Regulatory Strategy, Infectious

    vor 4 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **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,...

  • Director, Regional Regulatory Strategy, Infectious

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    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 forwardlooking,...

  • Manager, Regulatory Strategy

    vor 2 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the...

  • Manager, Regulatory Strategy, International

    Vor 5 Tagen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the...

  • Manager, Regulatory Strategy, International

    Vor 5 Tagen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Manager, Regulatory Strategy, International

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Vollzeit

    The Role:Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...

  • Manager Scientific Regulatory Strategy Neuchatel

    vor 2 Wochen

    Basel, Schweiz Philip Morris International Vollzeit

    Manager Scientific Regulatory Strategy - Neuchatel, Switzerland Be a part of a revolutionary change. At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and...

  • Director, Regional Regulatory Strategist

    vor 1 Monat

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **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,...

  • Director, Regional Regulatory Strategist

    vor 1 Woche

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **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,...

  • Early Development Regulatory Manager

    vor 2 Wochen

    Basel, Schweiz Manpower Vollzeit

    Mandated by one of our client companies, we are currenlty looking for a Regulatory Affairs Manager. The person in this role works with some independence under limited supervision to provide operational and strategic regulatory leadership for early development (ED) programs. **General information**: - Workload: 100% - Duration: 12 months - Remote work: No,...

  • Director, Regulatory Affairs, Regional Regulatory

    Vor 6 Tagen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: **Here's What You’ll Do**: Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, MAA etc.) Work with the International local regulatory leads in Canada, Asia,...

  • Director, Regulatory Affairs, Regional Regulatory

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Vollzeit

    The Role:Here's What You'll Do:Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, MAA etc.)Work with the International local regulatory leads in Canada, Asia, Latin America...

  • Global Program Regulatory Manager

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    394918BRGlobal Program Regulatory Manager (GPRM - Cardiometabolic):SwitzerlandAbout the role26 major approvals, 13 major submissions and 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially...

  • Global Program Regulatory Manager

    vor 2 Monaten

    Basel, Schweiz Novartis Vollzeit

    394918BR **Global Program Regulatory Manager (GPRM - Cardiometabolic)**: Switzerland **About the role** 26 major approvals, 13 major submissions and 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing...

  • Regulatory Manager

    vor 3 Wochen

    Basel, Schweiz nemensis ag Vollzeit

    For our customer, we are looking for an** Early Development Regulatory Manager (EDRM).** The EDRM works with some independence under limited supervision to provide operational and strategic regulatory leadership for early development (ED) programs. The EDRM executes the regulatory filings, coordinating planning, submission timelines, responses to HA queries,...

  • Global Program Regulatory Manager

    vor 3 Wochen

    Basel, Schweiz Universal-Job Vollzeit

    In this role you work with leading regulatory professionals around the world to provide strategic and operational regulatory direction and ensure the execution of regulatory plans in line with global regulatory strategy. You are responsible for integrating global strategy into regional submissions worldwide. You develop and implement plans for timely...