Manager Regulatory Affairs

Job Description

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.

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.

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

The Manager Regulatory Affairs serves as a core member of the BENELUX Cluster Regulatory Team, consisting of the Netherlands and BeLux affiliate, interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with countries applicable legislations and regulations pertaining to our portfolio (at all stages of the product’s life cycle) i.e. ensure that Gilead medicinal products can be

• developed
• authorized
• maintained on the market

ESSENTIAL DUTIES AND RESPONSIPILITIES

Job Overview

• Serves as a core member of the BeLux Affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders
• Ensures that Gilead complies with country’s applicable legislations and regulations linked to the Marketing Authorization (MA) / local licenses
• Ensures that the medicinal products in his/her responsibility can be developed, authorized and maintained on the market
• Serves as a core member or may lead project teams locally and may lead local initiatives. May also participate in above country teams

Job Responsibilities

• Manages or contributes to regulatory submissions to local Health Authority (HA), including assisting with/leading key aspects of initial MA application, assisting with/leading variations, safety reports, risk minimization measures, Dear Healthcare Provider Communications, compassionate use, early access, license renewals as well as clinical trial applications and amendments, which may require extensive interaction with departments outside of Regulatory Affairs (RA)
• Ensures compliant labeling for Gilead medicinal products and manages timely updates for assigned product(s)
• Manages interactions, negotiations and communication with local HAs and acts as the main point of contact for the local HAs for specific topics/products under their responsibility
• Helps ensure compliance with local law and regulation and consistency with global procedural documents including acting as a subject matter expert or assisting with the execution of audits and inspections within the affiliate
• Initiates or supports local process improvements and contributes to local and/or global process improvements which have a significant impact for RA and other departments, assesses proposed changes to local procedural documents and impact on existing processes
• Supports maintenance of GDP license and Quality Agreements, as required
• Support the management of quality defects, falsified or counterfeit products, batch recalls and stock out as required
• Supports local Affiliate, regional, Intl or Global RA teams on Affiliate matters
• May support risk assessments on specific local regulatory issues
• Helps prepare the Company for major changes in regulatory legislation and competitor information in the country for assigned product(s) or projects and communicates this internally to stakeholders
• Represents Regulatory Function at internal and external meetings or internal working parties
• Work is performed with minimal immediate direction from a senior RA professional
• May contribute to training or coaching of staff on key regulatory activities and updates under the direction of a senior RA professional

Knowledge & Skills

• Capable of leading small project teams
• Must have the ability to work and negotiate with a HA
• Ability to work on a number of projects with tight timelines
• Excellent verbal and written Dutch or French and English skills, organization skills and interpersonal communication skills required

Education & Experience

• 5+ years of experience in RA or other relevant industry experience with BS/BA. Degree in a scientific field is preferred.
• Good knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local affiliate
• Must be capable of developing and implementing regulatory initiatives and managing negotiations with the HA
• Knowledge in quality assurance, promotional and non-promotional review as well as pharmacovigilance is advantageous
• Experience in working in project teams
• Good working knowledge regarding country/national and regional HAs (people, system, processes and requirements) essential

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.