VP Global Regulatory Affairs Affiliates
Location
Foster, CA | United States
Job description
Job Details
VP Global Regulatory Affairs Affiliates United States - California - Foster CityUnited States - New Jersey - ParsippanyUnited Kingdom - Cambridge
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 believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description Gilead Sciences, Inc. is a research-based biopharmaceutical 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 Create Possible and improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include Oncology, Inflammatory Diseases, and Virology.
Since its founding in Foster City, California, in 1987, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, an impressive pipeline of investigational drugs across therapeutic areas, and over 14,000 employees in offices across six continents.
We are revolutionizing healthcare by bringing urgently needed medicines to patients with HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases, and cardiovascular conditions. Our portfolio of more than 25 marketed products includes an antibody-drug conjugate for the treatment of certain patients with unresectable locally advanced or metastatic triple-negative breast or locally advanced or metastatic urothelial cancers, two CAR T therapies approved for the treatment of adult patients with certain B cell lymphomas or Mantle Cell Lymphoma, and innovative complete treatment regimens for HIV and chronic hepatitis C infection available in once-daily single pills.
Millions of people around the world are living healthier lives because of innovative therapies developed by Gilead. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors working together and supporting each other to help make a real difference to the lives of patients.
Reporting to the SVP of Regulatory Affairs and Development Sustainability, the VP of Global RA Affiliates will provide leadership oversight of Gilead's global regulatory development efforts in China and Japan and the local regulatory activities across the world working with Gilead affiliates and designated distributors. This role is responsible for providing regulatory guidance, developing and implementing international regulatory strategies to efficiently bring new products to commercialization worldwide and ensure complaint post-approval lifecycle management. An important aspect of the role is to help improve international infrastructure and process improvements to enhance the efficiency of the Global RA Affiliate operating model with a view to enabling more simultaneous submissions and increasing strategic value of the Global Affiliates. The ideal candidate will have an in-depth knowledge of international regulatory requirements, and a proven track record of international business acumen. (The primary location is Foster City with possible locations Parsippany, NJ, Stockley Park, UK, or Cambridge, UK.)
The VP will be a member of the Regulatory Affairs Senior Leadership Team and as such will contribute to defining and executing the regulatory vision, roadmaps, initiatives and outcomes of the organization.
Key Responsibilities: - Provides leadership and management oversight of the Global Affiliate Team comprised of 4 subfunctions, namely China, Japan, ACE (Australia, Canada and Europe region) and IC/GPS (intercontinental) which oversees all regulatory activities across the affiliates and distributors around the world.
- Provides leadership for the regulatory strategies and activities in China and Japan that supports Gilead's Product Strategy Teams (PSTs) in the G. Ecosystem so that global development plans are executed to include China and Japan whilst minimizing lag times to submission and approval for products in the region.
- Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities optimizing their effectiveness to enable the timely and quality creation of local submissions.
- Recruits, retains, coaches, motivates and develops talent, fostering professional growth and ensuring a strong succession pipeline.
- Accountable for ensuring all regulatory activities across the affiliates are delivered in a compliant way that meets the business needs, such activities may include regulatory submissions, regulatory intelligence, quality assurance (GxP), pharmacovigilance, promotional and non-promotional materials/activity review and support to market access/business conduct.
- Play a pivotal role in representing Gilead's interests externally on the international stage and shaping global regulatory policies and the external regulatory environment.
- Play a significant leadership role in guiding and leading in a cross-functional, matrixed organization to partner and work effectively across all aspects of the global affiliate infrastructure.
- Forms strong, collaborative partnerships with key stakeholders across Regulatory Affairs, CMC Regulatory, Safety, Quality and other functions including General Managers of affiliates, to advance near-term regulatory goals and broader enterprise level objectives.
- Provides leadership expertise and insights to address complex regulatory and business challenges in the affiliates and designated distributors. Strategic advice pertains to product development, and other regulatory activities throughout the product life cycle undertaken by the affiliates and distributors.
- Sets clear expectation to create a culture, team capabilities and mindset in the affiliate regulatory infrastructure that seeks to create effective workflows to ensure efficient use of resources and accelerating the availability of Gilead's products worldwide.
- Initiates, and drives change management initiatives across regulatory affiliate organizations to ensure organizational effectiveness.
- Develops and manages budget effectively to achieve RA team and Gilead business goals.
- Accountable for ensure all processes and submissions adhere to local and international regulatory guidelines, laws, and standards.
- Stays current with regulatory trends, changes, and requirements related to international regulatory affairs and contributes to international policy development.
- Partner with other industry regulatory leaders, where appropriate, in a pre-competitive fashion to address macro issues affecting the industry internationally.
- Represents the Global Affiliate function at senior level internal meetings.
- Interpret international regulations on behalf of Gilead and work cross-functionally to develop a point of view on how regulations apply to Gilead and what actions, if any, are necessary.
- Accountable for the maintenance of Gilead's global portfolio of product licenses and management of associated regulatory commitments.
Qualifications: - Bachelor's degree in a relevant field; advanced degree (e.g., MBA, PhD) preferred.
- Proven leadership experience (15+ years) and skills, with the ability to inspire and mentor a diverse and global team.
- Exceptional verbal, written, communication skills and stakeholder management abilities.
- Strong interpersonal skills that facilitate collaboration across functions to identify business solutions on regulatory challenges and opportunities.
- Extensive in-depth knowledge of international regulatory requirements, including ICH requirements and regional requirements and understand current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
- A strong and long track record in attracting and retaining diverse top talent with a history of creating leaders and teams that succeed and thrive in a fast-paced, matrixed environment.
- A proven track record in ensuring flawless execution against a strong and enduring vision that ensures alignment and commitment across a broad array of internal and external stakeholders on the international stage.
- A proven track record of developing and implementing regulatory business strategies in the international space.
- Excellent influencing and negotiating skills with evidence of positive outcomes.
- Ability to skillfully navigate the executive matrix.
Gilead Core Values: - Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 EEO is the Law poster.
We are an equal opportunity employer. Apply online today at
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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