Associate Director, Regulatory Affairs CMC
2 weeks ago
Associate Director, Regulatory Affairs CMC United Kingdom - Uxbridge, United Kingdom - Cambridge Regulatory Regular 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 DescriptionWe 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 careers@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.
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:Share:
Job Requisition ID R0041443
Click below to return to the Gilead Careers site
Click below to see a list of upcoming events
Click below to return to the Kite, a Gilead company Careers site
#J-18808-Ljbffr-
(Senior) Director Regulatory Affairs CMC
2 months ago
United Kingdom Autolus Ltd Full timeVacancy for (Senior) Director Regulatory Affairs CMC Location: United Kingdom Job Summary Role Summary An exciting opportunity has arisen for an experienced CMC Regulatory Affairs Sr. Director to join the Autolus team to take a leadership role for developing global CMC regulatory strategies and content plans for products across Autolus’ cell and gene...
-
Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary:The...
-
Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary: ...
-
Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary:The...
-
Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary: ...
-
Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary: ...
-
Regulatory affairs CMC Consultant
2 weeks ago
United Kingdom Life Science People Full timeRegulatory affairs CMC Consultant Remote Tasks & Responsibilities : Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and...
-
Regulatory affairs CMC Consultant
2 weeks ago
United Kingdom Life Science People Full timeRegulatory affairs CMC Consultant Remote Tasks & Responsibilities : Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and...
-
Regulatory affairs CMC Consultant
2 weeks ago
United Kingdom Life Science People Full timeRegulatory affairs CMC ConsultantRemote Tasks & Responsibilities: Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the teamEnsure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval...
-
Regulatory affairs CMC Consultant
2 weeks ago
United Kingdom Life Science People Full timeRegulatory affairs CMC Consultant Remote Tasks & Responsibilities : Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable...
-
Regulatory affairs CMC Consultant
2 weeks ago
United Kingdom Life Science People Full timeRegulatory affairs CMC ConsultantRemote Tasks & Responsibilities: Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the teamEnsure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval...
-
Associate Director Regulatory Compliance
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. The Regulatory CMC...
-
Associate Director Regulatory Compliance
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. The Regulatory CMC...
-
Director Global Regulatory CMC Authoring
2 weeks ago
United Kingdom Proclinical Staffing Full timeProclinical is seeking a Director for Global Regulatory Affairs CMC. The successful candidate will be responsible for authoring global quality regulatory documentation for multiple medium-complexity projects. The role also involves defining and establishing platform approaches to the preparation of quality regulatory documentation used in development,...
-
Director Global Regulatory CMC Authoring
2 weeks ago
United Kingdom Proclinical Staffing Full timeProclinical is seeking a Director for Global Regulatory Affairs CMC. The successful candidate will be responsible for authoring global quality regulatory documentation for multiple medium-complexity projects. The role also involves defining and establishing platform approaches to the preparation of quality regulatory documentation used in development,...
-
Pensions Associate/Senior Associate/Director
2 weeks ago
United Kingdom Gilead Sciences, Inc. Full timeAssociate Director, Regulatory Affairs CMC Associate Director, Regulatory Affairs CMC United Kingdom - Uxbridge, United Kingdom - Cambridge Regulatory Regular Job Description 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...
-
Associate Director Regulatory Affairs
3 weeks ago
United Kingdom Life Science People Full timeAssociate Director Regulatory Affairs Remote Competitive salary + bonus + car allowance + shares/stocks Reporting to the Vice President of Regulatory Affairs, the Associate Director of Regulatory Affairs is responsible for providing regulatory oversight and support for both the operational and supervised strategic regulatory activities for, selected...
-
Associate Director Regulatory Affairs
3 weeks ago
United Kingdom Life Science People Full timeAssociate Director Regulatory Affairs Remote Competitive salary + bonus + car allowance + shares/stocks Reporting to the Vice President of Regulatory Affairs, the Associate Director of Regulatory Affairs is responsible for providing regulatory oversight and support for both the operational and supervised strategic regulatory activities for, selected...
-
Associate Director Regulatory Affairs
2 weeks ago
United Kingdom Life Science People Full timeAssociate Director Regulatory Affairs Remote Competitive salary + bonus + car allowance + shares/stocks Reporting to the Vice President of Regulatory Affairs, the Associate Director of Regulatory Affairs is responsible for providing regulatory oversight and support for both the operational and supervised strategic regulatory activities for, selected...
-
Associate Director Regulatory Affairs
2 weeks ago
United Kingdom Life Science People Full timeAssociate Director Regulatory Affairs Remote Competitive salary + bonus + car allowance + shares/stocks Reporting to the Vice President of Regulatory Affairs, the Associate Director of Regulatory Affairs is responsible for providing regulatory oversight and support for both the operational and supervised strategic regulatory activities for, selected...