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VP of Regulatory Affairs - International

Company: HCPro
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Description

The Role:

The VP of Regulatory Affairs - International is a newly created position and will have the opportunity to define and build the Regulatory Affairs function in Europe and Rest of the World for Moderna. This leader will work cross-functionally to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate, accounting for the complex interplay between European and International Health Agencies, and leveraging the mRNA platform technology. The Head of RA-International will bring a proven track record of building, leading and executing all the Regulatory Strategy for Europe and Rest of the World.

Here's What You ll Do:

Designs strategic vision for the Regulatory Affairs function in the EU/International and ensures its successful execution by headquarters and the respective project teams.

Represents Regulatory on the commercial and development committees of in the EU & International and is accountable for the effective management of regional regulatory activities

Designs the EU/International regional brand strategy for global and local brands in Europe

Shapes regulatory environment by active participation at HA meetings, when required

Develops and supports regionally external stakeholder management plans in cooperation with the regional management

Drives regional portfolio advocacy with key HAs in cooperation with the regional management team including accountability for negotiations with relevant country HA s

Sets strategic direction and leads the development of content, format and accountability for regulatory submissions and related supplements and amendments

Advises project teams regarding the development and implementation of regulatory strategy through the CMC, clinical and nonclinical development processes

Conducts risks and gaps assessment and Identifies potential areas of regulatory concern and responds to new government/regulatory developments

Monitors global development related to mRNA platform and advises project teams regarding the implementation of regulatory strategy through the CMC and clinical development processes

Establishes and maintains excellent relationships with EU/International health agencies

Negotiates directly and effectively with health agencies regarding company's filings

Drives policy and advocacy activities in the assigned countries in cooperation with the country Regulatory teams and EU/International policy roles

Shapes regulatory environment by participation at relevant trade associations and HA meetings

Provides the European and International perspective to Target Label Profile and the Company Core Data Sheet

Ensures appropriate level of resources and manages Regulatory budget

Here s What You ll Bring to the Table:

Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)

15+ years of experience in the Pharmaceutical industry and 12+ years of experience in Regulatory strategy

Experience with building and/or leading the Regulatory functions in European Affiliates

Expert knowledge of relevant FDA, EU, ICH guidelines and regulations and significant experience with regulatory filings

Experience with developing and implementing competitive regulatory strategies

Demonstrated track record in securing product approvals and maintaining a complex portfolio

Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance at EU and international level.

Direct experience of leading regulatory authority meetings in different phases of drug development

Regulatory knowledge across therapeutic areas including infectious diseases and vaccine development is preferable.

Demonstrated effective cross-functional and cross-cultural skills including influence at external industry meetings

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

Solid experience with line management and development of direct reports.

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

About Moderna :

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com .

Our Mission:

Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

#LI-KF1R2845

Job Information

Job ID: 54468393

Location:

Basel, United States

Position Title: VP, Regulatory Affairs - International

Please refer to the company's website or job descriptions to learn more about them.

Associate Director / Director, Quality Systems and Compliance

Executive Director, Nonclinical Development

100 Winners Circle, Suite 300 Brentwood, Tennessee 37027 (978) 624-4594

Keywords: HCPro, Cambridge , VP of Regulatory Affairs - International, Other , Cambridge, Massachusetts

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