Associate Director, Regulatory Affairs, Labeling
Location
Foster, CA | United States
Job description
Job Details
Associate Director, Regulatory Affairs, Labeling United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly
#CreatingPossible For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.
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 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 (including HIV treatment and prevention) 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 virology therapeutic area.
- 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.
- 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 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.
- Experience working within the virology therapeutic area 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.
The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact
[email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
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For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.
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