Associate Director, Regulatory Affairs CMC
4 months ago
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
We are looking for an experienced Regulatory professional to join our global team.
Location: Cambridge or Uxbridge.
In this role, you will be responsible for acting as one of the EU Regulatory leads for Kite's existing commercial and/or clinical programs. Your duties will include defining the regulatory strategy, plans, and objectives for assigned products or projects. Additionally, you will contribute to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities.
You will take the lead on CMC submissions and collaborate with headquarters' colleagues to shape dossier content for global rollout and life cycle management in EU-aligned regions. Serving as a Kite contact for regulatory authorities, you will oversee the preparation and maintenance of CMC regulatory submissions for assigned products or projects, guiding and advising colleagues to ensure thorough and compliant completion of these activities.
Furthermore, you will play a leadership role in ad hoc or special projects aimed at continuously improving or advancing Regulatory Affairs capabilities.
In your new role, you will:
Represent Regulatory Affairs and may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.
Provide strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
Participate on other sub-teams (e.g., Study Management, Clinical). Proactively identify regulatory or related risks/issues and develops mitigation and/or contingency plan.
Oversee and guide the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, investigational medicinal product dossiers (IMPDs), variations to the commercial marketing authorization and substantial modifications to the clinical trial (CMC).
Maintain submission content and updates in the appropriate electronic systems.
Your profile
We are all different, yet we all use our unique contributions to serve patients. We are looking for you if you have:
Degree in life sciences and solid relevant experience in CMC related regulatory affairs,
Strong life sciences background, ideally in cell & gene therapy.
Knowledge & Other Requirements
In-depth knowledge of current global and regional trends in biologics but ideally also cell and gene therapy regulatory affairs. Proven effectiveness applying this knowledge to optimize team delivery and results.
In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements. Evidence of prior successes in conducting HA interactions is a plus.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives to support a team-oriented, highly matrixed environment.
Demonstrated ability to learn quickly while being flexible and adaptable to change, and to move between projects easily and provide support/expertise where needed.
Demonstrates strong attention-to-detail and good organizational skills. Ability to communicate in a clear and concise manner verbally and in writing.
Excellent knowledge of Microsoft Office tools and the Veeva platform quality/regulatory/compliance systems expected.
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 for assistance.
For more information about equal employment opportunity protections, please view the ‘Know 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 jobs in France:
Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com
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