Sr. Director, Head of Global Regulatory Labeling Strategy
Sr. Director, Head of Global Regulatory Labeling Strategy
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1 Vacancy
Job Description
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 Modernas 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.
Heres What Youll 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 Modernas 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.
Heres What Youll Bring to the Table
Bachelors 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/adaptability: ability to adapt to and work effectively within a variety of situations and with various individuals and groups.
Relationship building teamwork and cooperation: builds and maintains strong working relationships with people
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.
- Best-in-class healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
- Savings and investment opportunities
- Location-specific perks and extras
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.
Our Working Model
As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
Moderna is a smoke-free alcohol-free and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Accommodations
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens U.S. lawful permanent residents asylees or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered contingent on the companys ability to obtain any required export control license.
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Required Experience:
Exec
Employment Type
Full-Time
