Senior Regulatory Associate- Oncology and Cell Therapy
Senior Regulatory Associate- Oncology and Cell Therapy
United Kingdom - London
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
For more information please visit Gilead.com
We currently have an exciting opportunity for a Senior Regulatory Associate based in the UK Affiliate at Gilead Sciences in High Holborn; focussed on the Oncology and Cell Therapy.
An affiliate Regulatory Affairs role, the Senior Regulatory Associate will assist in the local coordination and execution of regulatory submissions in compliance with Gilead's corporate standards and national regulatory requirements, and of Regulatory Affairs processes and deliverables for the UK and Ireland.
Reporting to the Director for Oncology and Cell Therapy, the role will involve the execution of EU regional regulatory strategy, including clinical trial application (CTA) submissions and promotional review for the UK and Ireland affiliate commercial affiliate.
Specific Job Requirements
- Expert on regulatory information and intelligence within the UK and Ireland
- Responsible for coordination with multiple stakeholders' national submissions and follow-up of all regulatory submissions, such as variations and clinical trials
- Reviewer for promotional and non-promotional activities and materials and ensuring their compliance with local guidance, codes of conduct and Gilead SOPs
- Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and subsequent process improvement initiatives
- Initiates or contribute to local process improvement initiatives and subsequent procedural document development
- Provide regulatory expertise for local business initiatives including market access, business compliance and medical led projects
- Responsible for ensuring product packaging and associated information is updated and maintained in accordance with product SmPCs
- Develop expertise in assign Therapeutic Area, and become Subject Matter Expert (SME) for assigned core Regulatory activities
- Responsible under guidance of line manager for own self-development and acquisition of required regulatory skills and knowledge
Knowledge, Experience & Skills
- Experience in Regulatory Affairs, in an affiliate or global role, or other relevant industry experience
- Science degree or relevant experience in Regulatory Affairs or related field
- Knowledge and awareness of the relevant regulatory guidelines and legislation,
- Knowledge and awareness of the relevant regulatory guidelines and legislation
- Experience in management of CTAs including amendments and other CT related submissions
- Experience in GxP compliance/variations desirable
- Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice would be advantageous
- Expert project management and time management
- Excellent organization skills
- Excellent verbal and written communication skills in English
- Excellent interpersonal skills
- Is recognized as a knowledgeable resource within the department on a range of regulatory topics
- Able to work equally well as part of a team or independently
- Strong teamwork and facilitation - effective at being a member of teams. Listens actively and responds constructively to needs and views of others.
- Delivery - gets the job done. Meets or exceeds expectations and exhibits a sense of urgency on critical time-dependant issues
- Demonstrates the ability to prioritize and work autonomously
- Persists despite obstacles and opposition
- Driven - self-drive to identify, initiate and implement projects and processes to address issues.
Gilead Core Values
- Integrity (Doing What's Right)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
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:
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---London/Senior-Regulatory-Associate--Oncology-and-Cell-Therapy_R0017145-1
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