Associate Director Global TA Regulatory Liaisons
Associate Director Global TA Regulatory Liaisons
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$ 182070 - 235620
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
You will act as the Regional Regulatory Lead on more complex or multiple products compounds indications or projects in the assigned therapeutic area. You will typically be assigned multiple products or projects to lead manage and oversee simultaneously. You will define the regulatory strategy plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for earlystage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on crossfunctional core and subteams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
EXAMPLE RESPONSIBILITIES:
As needed represents Gilead in negotiations with regulatory authorities.
Makes significant contributions to the ongoing development and refinement of regulatory strategies processes standards practices efficiencies and capabilities.
Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on crossfunctional/crossregional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and crossfunctional leaders and teams.
May participate on other Subteams (e.g. Study Management Clinical Nonclinical Biomarkers) or assign such to other colleagues and oversee and guide their subteam participation.
Defines the regulatory strategy for multiple Gilead products or projects.
Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
Oversees and guides the preparation compilation and timely filing of regulatory submissions which require crossfunctional interactions for commercial or investigational product(s). Examples include meeting requests briefing packages original Investigational New Drug (IND) IND amendment and routine submissions (e.g. Development Safety Update Reports / DSURs Investigator Brochure/ IB updates etc..
Oversees and approves the authoring of regulatory documents including meeting requests Module 1 documents for original IND etc.
Oversees and guides labeling packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
Critically reviews documents for submission to regulatory authorities.
May have one or more direct reports.
Provides matrix management and leadership to project teams.
Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation including budgets.
Ensures own work complies with established practices policies and processes and any regulatory or other requirements.
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.
U.S. Education & Experience
PharmD/PhD with 2 years relevant experience.
MA/MS/MBA with 8 years relevant experience.
BA/BS with 10 years relevant experience.
Significant regulatory quality compliance or related experience in the biopharma industry.
Proven track record in effectively setting and directing the regulatory or related strategy to successful conclusion for one or more products or key markets.
Experience and proven effectiveness working and negotiating with regulatory authorities.
Significant experience participating in crossfunctional projects and teams with responsibilities related to clinical trials or other drug development activities.
Line management (direct reports) experience is preferred.
Demonstrated abilities to effectively delegate and manage others as evidenced through either past people management or matrix management responsibilities.
Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
Knowledge & Other Requirements
Indepth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
Indepth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities as evidenced by strengths in assessing complex multidisciplinary data understanding and effectively advising on its regulatory implications.
Indepth knowledge of relevant health authorities (HAs) including people system processes and requirements as evidenced by past effectiveness and successes in conducting HA interactions.
Able to represent Gilead to regulatory authorities when managing standard and nonstandard negotiations.
Thorough knowledge of the drug development process including all key functions involved in the various stages of drug development from early research through postmarketing.
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.
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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Exec
Employment Type
Full-Time
