Sr. Director, Head of Global Regulatory Labeling Strategy

The Role
Within an end-to-end (E2E) labeling framework, manage a team of labeling strategy leads responsible for, in partnership with the GRS Strategy team, ensuring the development and implementation of regulatory labeling strategies to meet Moderna’s company objectives and the needs of patients.  This leader closely partners with the GRS Head of Labeling Operations and other Regulatory functions as well as stakeholders in Clinical Development, Commercial, Legal, Medical, Pharmacovigilance and others to ensure the timely creation, revision, and submission of compelling and compliant labeling.

Here’s What You’ll Do

• Labeling Responsibilities for Assigned Products:

• Provide regulatory expertise and guidance to internal stakeholders for the successful development and implementation of global regulatory labeling strategies

• Monitor the environment and maintain knowledge of evolving labeling regulations and industry standards and communicate changing requirements and impacts to stakeholders

• Provide Regulatory guidance on clinical development programs and evidence generation plans, including trial design, to enable promotion of clinical trial data and desired product claims.

• Ensure strong partnerships between Labeling Strategists and Global Regulatory Leads (GRLs) with respect to the development of Target Label Profiles (TLPs) to inform and support clinical development programs (Phases 1-4).

• Direct the preparation of new labeling text in conjunction with Regulatory Strategists and ensure labeling text meets regulatory labeling requirements.

• Direct submission of labeling materials and supporting documentation to regulatory authorities in accordance with submission requirements.

• Participate in labeling negotiations with global health authorities and ensure timely revisions and responses to labeling-related health authority requests

• Chair Executive Labeling Teams (ELT) meetings to review and approve new and updated CCDSs

• Manage and develop labeling strategy talent to meet Moderna’s needs of the future

• Serve as the Labeling Strategy expert on Regulatory sub teams addressing activities related to the development of labeling for regulatory submissions.

• Lead and serve as the Labeling expert on assigned product Global Labeling Team (GLT) meetings, advising on regulatory authority requirements and prior labeling negotiations. Ensure Labeling Strategy leads provide effective leadership of assigned product GLT meetings

• Liaise within the pharmaceutical/biotech industry to maintain awareness of evolving/emerging industry standards and trends. Where possible, influence the environment regarding labeling matters.

• Management Responsibilities:

• Provide leadership and career development support to labeling strategy leads.

• Interact with Regulatory senior management, leadership across other functions, and regulatory authorities as needed.

• Participate in forecasting and planning activities related to resources for the Regulatory Labeling team in anticipation of future needs.

Here’s What You’ll Bring to the Table

• Bachelor’s degree required; Advanced degree preferred

• At least 10 years of relevant experience in the pharmaceutical industry with preferably 6 years in Regulatory Affairs and specific experience in strategic labeling roles

• In-depth knowledge of the science and data related to assigned products and how this information translates into labeling language.

• Extensive knowledge of the competitive landscape and how other companies are addressing similar labeling issues.

• Experience leading teams, facilitating meetings and driving consensus and results.

• Excellent leadership, communication (verbal and written) and negotiation skills.

• Proven medical/technical writing skills.

• Labeling experience (CCDS, USPI, EU SmPC), preferably in infectious diseases or vaccines or other relevant industry experience.

• Integrity: overriding commitment to integrity and high standards for self and others.

• Strategic orientation: ability to link daily work with company and department visions

• Communication: ability to effectively explain, describe or convey information to a variety of audiences. Specifically, interacts effectively as member of Regulatory sub-teams, effectively communicates strategies to the Global Labeling Teams and collaborates with business partners, including affiliates and third parties.

• Develops others: involved in a genuine intent to foster development of direct reports and mentoring of colleagues

• Flexibility/adaptabil