Associate Regulatory Affairs Director

3 weeks ago

Cambridge Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

Global Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology)
Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R0040717 For Current Gilead Employees and Contractors:
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.we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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. Join Gilead and help create possible, together.
We are looking for a driven individual who is passionate about bringing transformational medicines to those in Europe and international countries with continued unmet medical need.
This is an exciting opportunity for a Regulatory Affairs Associate Director to join the Gilead Global Regulatory Affairs Oncology team to support drug development and registration of oncology assets. In this role you will need to provide provide regulatory strategy, leadership, and operational support for Gilead’s growing oncology development product portfolio, allowing you to strengthen your drug development and regulatory expertise . In the role you will be expected to work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead Global Regulatory Affairs.
Defines the regional regulatory strategy for development or marketed products, taking in consideration the latest precedent, regulatory intelligence, agency communications, and guidance.
Represents Gilead in discussions and at meetings with regulatory authorities (as required).
Works closely with Global Regulatory Leads to agree and ensure delivery of the local regulatory strategy to cross-functional leaders and teams.
Acts as representative for specific indications at Regulatory Project Team, and with cross-functional teams, for specified regions and products.
Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation as required.
Responsible for the content, preparation of moderately complex regulatory submissions, and their optimal execution in alignment with business needs.
Ensures regional product labelling is created and maintained in alignment with the Company Core Data Sheets and Company Core Safety Information.
Able to use internal electronic systems for planning, preparing, tracking, and storing submissions to regulatory agencies.
Contributes to the culture of continuous improvement across regulatory affairs helping team members learn and develop aspects of regulatory strategy and research, to lead or contribute to regional strategies.
Teamwork •Excellence •Accountability •Integrity •Inclusion
Detailed understanding of 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.
Knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Clear ability to lead cross-functional teams, and develop, communicate, and implement regulatory strategy.
Excellent verbal and written English communication skills, and demonstration of excellent interpersonal skills.
Excellent planning and organisational skills with the ability to work simultaneously on multiple projects with tight timelines.
Life science degree and demonstrated broad and/or depth of experience in pharmaceutical regulatory affairs across at least the European region, including leadership of major applications and health authority interactions.
Three days a week (Tues/Wed/Thurs) at the Stockley Park (Greater London) or Cambridge UK offices.
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:
Associate Director - Regulatory Affairs
locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago Senior Director, Global Oncology Therapeutic Area Safety Physician
locations United Kingdom - Cambridge time type Full time posted on Posted 2 Days Ago Senior Director, CMC Regulatory Affairs Policy, Advisory, & Intelligence
locations 2 Locations time type Full time posted on Posted 30+ Days Ago Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
#

  • Associate Director

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating...

  • Associate Director

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating...

  • Associate Regulatory Affairs Director

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R0040717 For Current Gilead Employees and Contractors: For more than 35 years, we’ve...

  • Global Regulatory Affairs, Associate Director

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R0040717 For Current Gilead Employees and Contractors: Please log onto your Internal Career...

  • Global Regulatory Affairs, Associate Director

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R0040717 For Current Gilead Employees and Contractors: Please log onto your Internal Career...

  • Associate Director

    1 month ago

    Cambridge, United Kingdom Gilead Sciences International, Ltd. Full time

    Description Regulatory Affairs Associate Director Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. Together we deliver life-saving therapies to patients in need. With...

  • Associate Director

    1 week ago

    Cambridge, United Kingdom Gilead Sciences Full time

    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...

  • Senior Director, Regulatory CMC Policy

    18 hours ago

    Cambridge, Cambridgeshire, United Kingdom Turner Regulatory Full time

    Senior Director, Regulatory CMC Policy & Intelligence Superb senior role in Regulatory CMC Policy & Intelligence and a key hire for a dynamic and fast-growing Biopharma. Leadership, influencing and advising skills both internally and externally. This outstanding role requires the candidate to provide EU Regulatory Intelligence expertise in order to steer the...

  • Regulatory Affairs Labelling Associate Project Manager contract job

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Regulatory Affairs Labelling Associate Project Manager contract job Your new company This well-known biopharmaceutical company is looking for a Regulatory Affairs Labelling Associate Project Manager to join their Labelling team on a contracting basis. This is a 12-month contract job with scope for extension and is fully remote. Your new role As...

  • Senior Planning Associate Director

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and...

  • Senior Planning Associate Director

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and...

  • Global Regulatory Affairs, Associate Director

    1 month ago

    Cambridge, United Kingdom Gilead Sciences International, Ltd. Full time

    Description We are looking for a driven individual who is passionate about bringing transformational medicines to those in Europe and international countries with continued unmet medical need. This is an exciting opportunity for a Regulatory Affairs Associate Director to join the Gilead Global Regulatory Affairs Oncology team to support drug...

  • Regulatory Project Manager

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Regulatory Affairs Labelling Associate Project Manager contract job This well-known biopharmaceutical company is looking for a Regulatory Affairs Labelling Associate Project Manager to join their Labelling team on a contracting basis. This is a 12-month contract job with scope for extension and is fully remote. As part of the Global Labelling Strategy...

  • Senior Manager/Director of Regulatory Affairs

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my biotechnology client. You will...

  • Associate Director, Regulatory Affairs

    1 month ago

    Cambridge, United Kingdom Relay Therapeutics Full time

    The Opportunity: We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to ​define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the global regulatory lead on relevant project teams ​to...

  • Senior Manager Regulatory Affairs Vendor Governance

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Senior Manager Regulatory Affairs Vendor Governance page is loaded Senior Manager Regulatory Affairs Vendor Governance Apply locations United Kingdom - Cambridge time type Full time posted on Posted 6 Days Ago job requisition id R0040568 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At...

  • Regulatory Affairs Associate

    1 month ago

    Cambridge, United Kingdom Proclinical Full time

    Proclinical are recruiting for a Regulatory Affairs Associate - II to join a pharmaceutical organisation. This role is on a contract basis and is located in either Cambridge or Uxbridge with hybrid working available. **Responsibilities**: - Conduct workflows and processes concerning document tracking, indexing, retrieving, and disseminating information to...

  • Regulatory Affairs Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Your New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract...

  • Regulatory Affairs Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Your New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for...

  • Regulatory Affairs Specialist

    1 month ago

    Cambridge, United Kingdom Vector Recruitment Limited Full time

    Regulatory Affairs Specialist £45k-£55k (dep on exp) Cambridge We have a brand-new vacancy for a Regulatory Affairs Specialist to join a fascinating Cambridge based R&D technology company. This business is very well established and is undergoing rapid growth due to the impact that their market disruptive technology is having on the medical...