Associate Director, Regulatory Affairs - San Mateo - Gilead Sciences, Inc.

Description

Associate Director, Regulatory Affairs - Global Labeling

The following information aims to provide potential candidates with a better understanding of the requirements for this role.

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies.

You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology 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, oversee, review, and approve the work of a team of direct reports. 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, and standards, etc.

Key Responsibilities:

• Individual contributor, with potential leadership opportunities to mentor and coach others, supporting their development and career interests.
  
• Leads or otherwise contributes to the development of the labeling strategy for multiple products and indications.
  
• Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology 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.
  

Preferred Qualifications:

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.

Preferred Education & Experience

• PharmD/PhD with 2+ 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 strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple medicinal products.
  
• Experience in NDA/BLA labeling and labeling negotiations.
  
• Significant experience participating in cross-functional projects and teams.
  
• Experience authoring and implementing processes.
  
• Line management (direct reports) experience.
  
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
  

Knowledge & Other Requirements

• In-depth knowledge of labeling requirements and guidance, including industry best practices and standards.
  
• Demonstrates extensive understanding of competitor labeling, strong therapeutic area knowledge, and CCDS/USPI expertise.
  
• Demonstrates ability to rapidly learn new therapeutic areas.
  
• Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.
  
• Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
  
• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
  
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, and/or initiatives.
  
• Strong interpersonal skills and understanding of team dynamics.
  
• Strong communication and organizational skills.
  
• Strong negotiation and conflict resolution skills.
  
• When needed, ability to travel.
  

People leader accountabilities:

• Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
  
• Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
  
• Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. xhmxlyz They provide the support needed to remove barriers and connect their team to the broader ecosystem.