Senior Planning Associate Director
2 weeks ago
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 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.
Regulatory Affairs Associate Director
With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.
We are looking for a driven individual who is passionate about bringing transformational medicines to those in the “International region” 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 leadership role you will provide strategic and technical advice from development throughout the whole product lifecycle for the growing Gilead Oncology projects/product portfolio.
Responsible for formulating and leading regulatory strategies for designated products in the International region. This ranges from new product licenses to lifecycle activities and have oversight of all regulatory aspects of the application.
Partner within Global Regulatory affairs (including Global Regulatory Leads), the Development and Commercial organization. To lead collaborations with cross functional partners to ensure optimal development execution of the agreed regulatory strategy
Responsible for overseeing the preparation of regulatory submissions products in the therapeutic area and execution of agreed strategies within the region
Deep and expert understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence
Ensures that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
Participates and leads regulatory team meetings and recognized as a knowledgeable resource for Regulatory Affairs in other departments.
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
Direct experience in regulatory affairs in pharmaceutical industry across International markets, in regulatory submissions and good understanding of the drug development process from development through to post-marketing.
In depth knowledge of regulatory requirements, including ICH requirements and regional requirements. Has appreciation of current global and regional trends in Regulatory Affairs.
Knowledge of current global and regional trends in biopharmaceutical regulatory affairs with proven effectiveness applying this knowledge to optimize team deliverables and results within the International Region.
Excellent organizational skills and ability to work on several projects with tight timelines.
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 International region, including leadership of major applications and support of associated health authority interactions.
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. Inclusion (encouraging diversity)
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). For Current Gilead Employees and Contractors:
Global Regulatory Affairs, Associate Director (Oncology)
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locations 2 Locations time type Full time posted on Posted 30+ Days Ago Senior Manager Regulatory Affairs Vendor Governance
locations United Kingdom - Cambridge time type Full time posted on Posted 6 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.
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