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Regulatory Affairs Lead
3 weeks ago
Spark Therapeutics London, United KingdomJoin the Spark Team · We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. · We don't follow foo ...
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Public Affairs Lead
4 days ago
The National Lottery Community Fund London, United Kingdom**Details**: · **Reference number**: · **Salary**: · - £46,785 - £51,039- A Civil Service Pension with an average employer contribution of 27%**Job grade**: · - Senior Executive Officer**Contract type**: · - Fixed term**Length of employment**: · - Six Months**Type of role**: · - ...
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Regulatory Affairs Lead
3 weeks ago
Haleon Weybridge, United Kingdom**Job Description**: · **Site Name**: UK - Surrey - Weybridge · **Posted Date**: Feb · Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our glo ...
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External Affairs Lead
2 days ago
Heathrow London, United KingdomThis is a new role in our dynamic and growing Policy and Public Affairs team. It offers a great opportunity to manage Heathrow's relationships large business groups, chambers of commerce and third-party stakeholders across the nations and regions of the UK. Given the unique role ...
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Public Affairs and Policy Lead
2 weeks ago
NFP People Limited London, United KingdomPublic Affairs and Policy Lead · We are looking for a Public Affairs and Policy Lead to join the team in this rewarding role offering flexible and hybrid working. · **Position**: Public Affairs and Policy Lead · **Location**: London/hybrid (The job is based at the office in Londo ...
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Nutrition and Scientific Affairs Lead
3 weeks ago
Tate & Lyle London, United KingdomWe are looking for an experienced **Nutrition and Scientific Affairs professional **on a **6-month fixed-term contract **to join our Global Nutrition team to lead specific multi-functional projects to deliver our strategy on FOP claims and innovation and to support our growth amb ...
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External Affairs Lead
3 weeks ago
Thames Water Utilites Reading, United KingdomWorking at Thames Water's Strategic Resource Options combines the excitement of tackling complex water-related challenges, working with challenging stakeholders, and enjoying personal and professional growth in a collaborative and innovative environment. Your efforts will make a ...
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Regulatory Affairs Lead
2 weeks ago
IQVIA Reading, United KingdomIQVIA have a fantastic opportunity for a Regulatory Affairs Lead to work for a growing pharmaceutical company. You will be joining a small team responsible for a range of products and therapy areas. It is a fantastic time to join the company as they are lots of growth potential a ...
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Eu Regulatory Affairs Lead
3 weeks ago
Spark Therapeutics London, United KingdomJoin the Spark Team · We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treat ...
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Regulatory Affairs Lead
2 days ago
Clearline Recruitment Welwyn, United Kingdom**Job Title**:Regulatory Affairs Lead · **Location**:Welwyn (Hybrid, 2-3 days in office per week) · **Salary**:£110-£120 per hour (UMB) · **Full Time** · **6-month contract inside IR35** · Our client is a leading name in the pharmaceutical industry globally, who are looking to hi ...
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Government Affairs Lead London, United Kingdom
2 weeks ago
Philip Morris International London, United Kingdom'Be a part of a revolutionary change' · About us · At PMI we've chosen to do something incredible. We're totally transforming our business and building our future on smoke-free products · With huge change comes huge opportunity. So, wherever you join us, you'll enjoy the freedom ...
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Peter Childs Ltd (PCL) London, United KingdomLocation: · - London- Industry: · - Public Affairs- Communications- In House- Salary: · - £ highly competitive- Start Date: · - Feb/March 22- Duration: · - 6 months- Contact Name: · - Caroline Ivory- A leadership role with an international FMCG business, you'll develop the global ...
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UCB Slough, United Kingdom**Make your mark for patients** · We are looking for **an External Affairs and National Policy Lead **who is insightful, proactive and a leader to join our **Access, Pricing and External Engagement (APEX)** department based out of our office in **Slough, United Kingdom.** · **Abo ...
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Regional Medical Affairs Operations Lead Eu
3 weeks ago
Seqirus Maidenhead, United KingdomThe Associate Director develops the strategy and implementation surrounding the collection, preparation, and dissemination of medical and scientific information on CSL Seqirus' products externally to physicians, pharmacists, investigators, health care institutions, agencies, pati ...
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Medical Affairs Lead
6 days ago
Walker Cole International england, United KingdomWalker Cole International is supporting one of its clients with their search for a Medical Affairs Lead. This is an opportunity to join a growing business with a broad portfolio covering Prescription Medicines (Rx), Cosmetics, Medical Devices and Homecare products. · The Medical ...
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Regulatory Affairs Lead
6 days ago
BioTalent united kingdom, United KingdomRegulatory Affairs Lead – Remote – Competitive Package · BioTalent are exclusively supporting an innovative UK based start up AI-backed software medical device company in their search for an experienced Software as a Medical Device (SaMD) Regulatory Affairs Lead. The company aims ...
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Medical Affairs Lead
5 days ago
Walker Cole International London, United KingdomWalker Cole International is supporting one of its clients with their search for a Medical Affairs Lead. This is an opportunity to join a growing business with a broad portfolio covering Prescription Medicines (Rx), Cosmetics, Medical Devices and Homecare products. · The Medical ...
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Regulatory Affairs Lead
5 days ago
BioTalent London, United KingdomRegulatory Affairs Lead – Remote – Competitive Package · BioTalent are exclusively supporting an innovative UK based start up AI-backed software medical device company in their search for an experienced Software as a Medical Device (SaMD) Regulatory Affairs Lead. The company aims ...
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Public Affairs Lead
3 weeks ago
UK Civil Service London, United KingdomJob summary · The National Lottery Promotions Unit (NLPU) raises positive public awareness of National Lottery brand and the funding which changes the lives of ordinary people through the �30 million it raises every week for good causes all across the UK. National Lottery players ...
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Public Affairs Lead
3 weeks ago
BIG LOTTERY FUND London, United Kingdom Full timeThe National Lottery Promotions Unit (NLPU) raises positive public awareness of National Lottery brand and the funding which changes the lives of ordinary people through the £30 million it raises every week for good causes all across the UK. National Lottery players help build lo ...
Regulatory Risk Affairs Lead - Brentford, Greater London, United Kingdom - GlaxoSmithKline
Description
With increasing needs in Quality, Compliance, and Safety, the harmonization, simplification and acceleration of work processes and systems will deliver critical benefits to ensure delivery of the future portfolio for GSK.
Supporting R&D, we are a cross-functional team with deep expertise in the Quality Management System, risk management, safety, compliance, deviation management, training, documentation, and data management.
This department plays a critical role in developing our compliance strategies, transforming our technical capabilities, and driving our Quality culture, all while ensuring we maintain our License to Operate.
As Compliance Solutions Lead you will be responsible for ensuring that the Medicine Development and Supply (MDS) organization is in a compliant state with respect to regulations and GSK policies/procedures, while building a strong compliance culture in the organization.
The holder will work effectively in a matrix across business functions to ensure that compliance requirements are clearly identified and understood, risks are proactively managed and mitigated, problems are rapidly and thoroughly investigated, and best practices are established.
Designing and continuously improving compliance processes that will impact MDSIdentifying compliance approaches and strategies which will ensure a 'now and future-ready' organization
Measuring the performance of the MDS organization and using this data to proactively identify issues, mitigate risks, and generate solutions which improve compliance and efficiency
Leading teams/sub-teams and supporting investigations, activities, or risk mitigation actions in areas of expertise
Leading data analysis and trending for key metrics, detecting and highlighting signals through the appropriate escalation channels
Participating in appropriate Tiered Quality Councils and/or Risk Councils, including generation and analysis of data, with a focus on proactive monitoring
Authoring/reviewing SOPs and other documents necessary to support the Quality Management System
Driving Quality Culture initiatives within the MDS organization
Bachelor's Degree with 3+ years' experience in GxP processes supporting drug development and/or supply.
Experience in compliance requirements (external and/or within GSK) in operational compliance/product quality. Specifically, knowledge of the Internal Control Framework, external regulatory requirements regarding data (e.g. data integrity, ALCOA CCEA), and risk management.
Experience analyzing data to measure and monitor compliance and drive continuous improvement
Ability to escalate issues and recommendations to management for discussion in a timely manner.
Experience leading a global matrix team to deliver business relevant compliance solutions
Attention to detail, with the ability to operate at both a detailed and summary level, and to put data analysis into context by seeing the bigger picture, to spot trends and extrapolate
Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.
In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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