Associate Director, Regulatory Affairs, Labeling

1 week ago

Boston, United States Gilead Sciences Full time

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

**Job Description**:

- Job Description- You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the oncology therapeutic area. You will lead various Core Labeling Working Group (CLWG), Target Product Label (TPL), and U.S. Product Information (USPI) team meetings. You will represent RA Labeling across all organizational levels relevant to assigned products and/or other activities. You will manage complex labeling negotiations with regulatory authorities. You will communicate labeling and other relevant updates or changes to cross-functional leaders and teams. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will train cross-functional partners and teams on labeling processes, policies, procedures, standards, etc.- EXAMPLE RESPONSIBILITIES:- Leads or otherwise contributes to the development of the labeling strategy for multiple products and indications in the oncology therapeutic area.
- Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the oncology therapeutic area.
- Provides strategic advice and guidance to cross-functional partners and stakeholders.
- Leads and facilitates cross-functional labeling and related forums and meetings, such as CLWG, TPL, and USPI team meetings.
- Leads or otherwise contributes to key system and process improvements.
- Represents or otherwise oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on joint labeling / safety meetings with partner companies.
- Oversees and guides Company Core Data Sheet (CCDS)/USPI review, approval, distribution, and tracking. Ensures updates to the CCDS are implemented in the USPI.
- Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories. Performs team and/or final review of ex-U.S. labeling.
- Manages complex labeling negotiations with regulatory authorities.
- Coaches and advises less experienced colleagues in completing their work and developing their regulatory capabilities.
- Leads or otherwise contributes to special projects that advance the capabilities of Regulatory Affairs.
- Trains other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling.
- Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.
- May manage direct report(s). Hires, develops, and retains diverse top talent in the team. Sets clear and elevating goals for the team and individuals direct reports. Coaches direct reports on their performance, development, and career interests.-
- REQUIREMENTS:
- We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.- Education & Experience-
- PharmD/PhD with 4+ years’ relevant experience.
- MA/MS/MBA with 8+ years’ relevant experience.
- BA/BS with 10+ years’ relevant experience.
- 4+ years’ experience in prescription drug labeling.
- Significant regulatory experience in the biopharma industry is strongly preferred.
- Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products.
- Significant experience contributing to the development of regulatory labeling or related

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