Regulatory Affairs Manager

2 weeks ago

Ware Hertfordshire, United Kingdom GlaxoSmithKline Full time

Site Name: UK - Hertfordshire - Ware RD, Durham Blackwell Street, GSK House, USA - Pennsylvania - Upper Providence
As Regulatory Manager for devices, you will manage the overall global regulatory and advocacy strategy for GSK’s portfolio of combination product devices (injectable and inhalation) across modalities and lifecycle
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Represent Global CMC Regulatory advising teams on global regulations and guidelines and providing strategic direction to cross-functional matrix project teams on medical device and drug/device combination product related topics.
Ensure Global CMC Regulatory have processes and procedures in place to stay in compliance with those regulations.
Be a key contact for external advocacy on device-related topics.
When needed, participate in corporate evaluation and provide CMC Regulatory support/advice to in-licensing and divestment projects.
Deliver CMC device-related regulatory strategy to support major submissions, RTQs, agency meetings, inspections (e.g. PAIs) or quality incidents (PIRCs). Detailed knowledge of drug and device development, and manufacturing and supply processes, with direct involvement in regulatory submission preparation.
Detailed working knowledge of worldwide CMC device-related regulatory requirements and successful track record of delivering dossiers that comply with these.
Demonstrated ability to influence the global internal/external regulatory environment. Successfully influenced and negotiated issues with regulatory agencies and personnel in a variety of settings.
Proven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
Experience of being involved in/leading business critical initiatives within and external to the organisation.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. 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).
While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. recruitment@gsk.We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
#

  • Regulatory Affairs Manager

    4 weeks ago

    Hertfordshire, United Kingdom Reed Scientific Full time

    I am currently recruiting for a Head of Regulatory for a global pharmaceutical company based in the Hertfordshire area. Are you open to work? If so, here are some details for the role: **6 Month FTC** **Daily: £110.00 - £120.00ph Umbrella.** **Hertfordshire area, UK** **About the Job** - Takes accountability to maximise the regulatory departments value...

  • Regulatory Affairs Officer

    1 month ago

    Hertfordshire, United Kingdom Real Staffing Full time

    **Regulatory Affairs Officer** **Hertfordshire -Pharmaceuticals** I am currently working with an exciting, well funded start-up Pharmaceuticals company based in Hertfordshire who manufacture and supply prescription medicines across the UK and who are looking for a site-based Regulatory Affairs Officer to join the teamon a permanent basis. Reporting to the...

  • Regulatory Affairs Officer

    1 month ago

    Hertford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Background Neon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and...

  • Regulatory Affairs Officer

    2 days ago

    Hertford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Job Description Background Neon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant...

  • Regulatory Affairs Officer

    1 month ago

    Hertford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Background Neon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and...

  • Regulatory Affairs Officer

    4 weeks ago

    Hertford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Background Neon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and...

  • Regulatory Affairs Officer

    3 weeks ago

    Hertford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Neon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and is looking...

  • Regulatory Affairs Officer

    1 month ago

    Hertford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Background Neon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and...

  • Global Senior Regulatory Affairs Manager Labelling

    4 weeks ago

    Hertfordshire, United Kingdom Page Group Full time

    Excellent opportunity to lead, manage and implement global labelling processes for a well renowned global pharmaceutical business. **Client Details** I have partnered with a global leading research based pharmaceutical company who specialise in oncology and neurology. They offer flexible hybrid working and UK head office is based in Hertfordshire. Due to...

  • Regulatory Affairs Consultant

    2 weeks ago

    Bishop's Stortford, Hertfordshire, United Kingdom Hobson Prior International Ltd Full time

    Principal Consultant - Clinical (Remote - UK Based) Hobson Prior is seeking a Principal Clinical Consultant with a strong background in clinical development and regulatory affairs. This role will involve providing strategic, technical, and regulatory advice to clients in the development of human medicinal products across a wide range of therapeutic...

  • Regulatory Documentation Scientist

    4 weeks ago

    Hertfordshire, United Kingdom Reed Scientific Full time

    **Regulatory Documentation Scientist** **12 Month FTC** **Hybrid working; in office as required** - The first week will need to be in the office for training._ **Daily: £55.00 - £70.00ph LTD/Umbrella.** **Hertfordshire area, UK** REED Scientific are representing a global pharmaceutical company whose achievements help to transform the lives of millions...

  • Regulatory Affairs Officer

    3 weeks ago

    North Hertfordshire, Hertfordshire, United Kingdom Vector Recruitment Full time

    Compliance / Quality Administrator – Medical Devices We are looking for a Compliance / Quality Administrator to join a dynamic company developing an array of products for the medical and healthcare industry. The company is growing and offering many opportunities for personal career development in addition to a wide variety of new projects to work on.As...

  • Senior Regulatory Affairs Product Manager

    1 month ago

    Watford, Hertfordshire, United Kingdom Ntice Search Solutions Full time

    Please note: only candidates based in the UK with automotive manufacturing experience will be considered for this role My client, a leading automotive manufacturer is looking for a Product Compliance Manager to join their team. A Product Compliance Manager plays a critical role in ensuring that the company's products meet all regulatory requirements,...

  • Trainee Regulatory Assistant

    4 weeks ago

    Ware, United Kingdom LUXE Recruitment Ltd Full time

    We have an exciting opportunity to join a great client of ours as a Regulatory Assistant. The key objectives of the role are to provide effective and efficient support to the Regulatory Manager & Specialists in implementing the Regulatory Group Strategy. This will involve supporting customers with regulatory requests. **Duties Include**: - Provide...

  • Senior Manager/Director of Regulatory Affairs

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom Currys Full time

    Regulatory Compliance Manager Stevenage - Transport Office (LM0228) / Hybrid - Bessemer Drive, Stevenage, SG1 2DL, you'll be required to work in the office approx. twice a week Permanent Full Time Grade 4 Hours - 37 per week, Monday to Friday, part-time would be considered for the right candidate Our passion at Currys is helping everyone enjoy the...

  • Quality Manager

    7 days ago

    Hertfordshire, United Kingdom Reed Scientific Full time

    REED are working with a leading medical device manufacturer based in the Hertfordshire area to fill a vacancy for a **Quality Assurance/Regulatory Affairs Manager**. The company manufactures and supplies a number of Class I, IIA and IIB medical devices within the Suction, Oxygen Therapy market to UK Hospitals and Distributors worldwide. **About the Job** -...

  • Regulatory Affairs and Product Safety Specialist

    3 weeks ago

    Watford, Hertfordshire, United Kingdom TJX EUROPE Full time

    We are part of the TJX Family which includes TK Maxx, and Homesense in Europe and the UK and across the rest of the world you will find us as TJ Maxx, Marshalls, HomeGoods, Sierra and Winners.Every day is an opportunity to discover something new about our business, our partnerships and even something exciting about yourself. The Merchandise Compliance Team...

  • Dispute Resolution Manager with Immediate Start

    18 hours ago

    Hitchin, Hertfordshire, United Kingdom SEC Life Sciences Full time

    Join a dynamic Clinical Research Organisation (CRO) that is committed to delivering life-changing medicines to patients across the globe. With a rich blend of expertise in Clinical Development, Clinical Trial Supply, and Early Access Programmes, this organisation offers a unique and seamless service to its pharmaceutical and biotech clients. Lead and...

  • Compliance and Regulatory Risk Manager

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    Risk & Compliance Manager GSC R&D Engineering Services provides Facilities Management and Capital Projects delivery for Technical R&D sites within GSC’s Engineering and EHS organisation. The purpose of this role is to ensure the consistent delivery of facilities and engineering services to R&D sites globally, working to ensure cost, quality and...

  • Data Analytics

    2 weeks ago

    Ware, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    We are looking for an experienced data analytics professional to manage our Data analytics and PAT team at GSK’s Ware manufacturing and R&D sites. This role is a key component for the long-term strategy for the application of modeling and PAT platforms at the Ware manufacturing (commercial production) and R&D sites. The Data Analytics & PAT (Process...