- Provide high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approvals in international markets, regulatory strategic development plans and risk assessments and lead Health Authority interactions
- Oversee, contribute to and/or prepare regulatory submissions.
- Perform and prepare due diligence assessments that may include risk mitigation strategies.
- Prepare regulatory teams for and lead meetings, including face-to-face, with Health Authorities
- Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance.
- Manage the development of the ongoing global regulatory strategy.
- Marketing access activities including pricing/contracts/product listingsESSENTIAL REQUIREMENTS FOR ROLE
- Postgraduate degree (MS/PhD/PharmD) in Pharmacy, Biological Sciences, or other related discipline
- 15+ years global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry
- Solid knowledge of FDA, EMA and other global regulations and ICH guidelines
- Expert in product development and experience in early to late stage as well as post approval phases
- Demonstrated experience in leading face-to-face meetings with FDA, EMA and/or other Health Authorities
- Preparation of New Drug Applications and Marketing Authorisation Applications in eCTD format
- Obtain Orphan Drug Designations in Europe and US
- High level of personal integrity and ethical behaviour
- Strong leadership and staff development skills
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Director of Compliance
2 days ago
James Andrews Recruitment Solutions Ltd Surrey, United KingdomWe are currently working in partnership with an established and renowned Housing Association, based in Surrey, who are recruiting for a Director of Compliance. The salary is £100,000 per annum. · The ideal candidate will have experience managing statutory compliance, specialist s ...
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Director of Compliance
1 day ago
James Andrews Recruitment Solutions Ltd Surrey, United KingdomJob Description · We are currently working in partnership with an established and renowned Housing Association, based in Surrey, who are recruiting for a Director of Compliance. The salary is £100,000 per annum. · The ideal candidate will have experience managing statutory compli ...
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Compliance Manager
4 days ago
Byron Recruitment Surrey, United KingdomOur client, a hugely successful multi-discipline business based in Surrey are looking to recruit a Compliance Manager to be based out of their UK Head Office, easily accessible from London and Surrey / Sussex borders. · You will have gained extensive experience or working within ...
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International Tax Manager
3 days ago
Signet Resources Surrey, United Kingdom**Are you an experienced International Tax Manager seeking a fantastic opportunity with a leading global organisation based in Staines?** · We are recruiting for an International Tax Manager for an innovative global technology business. Reporting to the Group Finance Director, th ...
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Assistant Director
3 days ago
Social Work Partners Surrey, United KingdomSocial Work Partners were established to make a positive difference across the Social Care and Work recruitment market, guided by our principals - Care, Communication and Community. Our team have been specially chosen due to their experience and will workwith you to support and d ...
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Interim Tax Manager
5 days ago
Signet Resources Surrey, United Kingdom**Are you an experienced International Tax Manager seeking a fantastic opportunity with a leading global organisation based in Staines?** · We are recruiting for an Interim Tax Manager for an innovative global technology business. Reporting to the Group Finance Director, this off ...
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Interim Tax Manager
5 days ago
Signet Resources Surrey, United Kingdom**Are you an experienced International Tax Manager seeking a fantastic opportunity with a leading global organisation based in Staines?** · We are recruiting for an Interim Tax Manager for an innovative global technology business. Reporting to the Group Finance Director, this off ...
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Regional People Partner
5 days ago
Talent Group Surrey, United KingdomRole**:Regional People Partner** · Salary**:Great Package, Car or Car Allowance** · Location**:M4 / M40 Corridor (Hybrid Working)** · Brand**:Award winning Retailer** · We are excited to be partnering with one of the UKs Fastest Growing Independent Builders on a fantastic new HR ...
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Assistant Director
1 week ago
Medport Global Surrey, United Kingdom**Role Purpose** · Reporting to the Director for Education, Lifelong Learning and Culture this role will be responsible for the direction and delivery of the council's ambition to transform the SEND system in Surrey alongside key partners. The post holder will lead the design and ...
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Ward Administrator
6 days ago
Priory Healthcare Surrey, United Kingdom**_Ready for the recognition _**_and rewards you deserve?_**: · **We don't just talk about putting employees first. We know that Priory wouldn't exist without their combined energy, expertise and effort. So we invest heavily in training, provide first-class support, promote colla ...
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Head of Finance
4 days ago
Solution22 Surrey, United Kingdom**Head Office, H.M.P. High Down, Sutton, High Down Lane, Surrey**: · **Contract: Full Time Permanent (we welcome conversations around flexible & hybrid working)** · **Salary: Up to £50,000 FTE** · **Location: Head Office is located in HMP High Down Conference Centre, near Sutton. ...
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Contracts Manager
1 day ago
Potensis Selection Limited Surrey, United Kingdom**Contracts Manager · - Surrey/Hampshire - £85,000 -£105,000 (per annum) + Car Allowance + Fuel Card + Annual Bonus** · Our client is a major UK housebuilder and leading provider of desirable new homes across the South of England, the Midlands and Scotland. Driven by a mission to ...
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Programme Lead
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Social Work Partners Surrey, United KingdomSocial Work Partners were established to make a positive difference across the Social Care and Work recruitment market, guided by our principals - Care, Communication and Community. Our team have been specially chosen due to their experience and will workwith you to support and d ...
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Senior Quality Assurance Officer
1 week ago
Apex International Recruitment Surrey, United Kingdom**Details**: · - Full-time permanent position · - Hybrid working - 2 days office (Surrey), 3 days WFH · - Competitive package · **The Role**: · As one of our Senior Quality Assurance (QA) Officers you will provide vital QA support and experience to our Operations teams in the UK ...
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Online Creative Lead
1 week ago
Hill's Pet Nutrition Surrey, United KingdomNo Relocation Assistance Offered · Surrey, England, United Kingdom · **Location: Guildford, UK** · **Job Function: Mktg OAC** · **Reporting to: eMarketing Director** · **At Hill's we have a purpose. Every day around the world, we transform the lives of millions of pet families th ...
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Finance Business Partner
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ISS Facility Services Surrey, United Kingdom**Healthcare**: · *** · **Business Area: Healthcare**: · *** · **Place of Work: Surrey** · *** · **Contract Type: Permanent** · *** · **Hours: 40** · *** · *** · **Context** · *** · **Finance Business Partner** · *** · **Surrey** · *** · **Competitive salary with excellent benefi ...
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Director of Operations
4 days ago
Linq Healthcare Recruitment Specialists Surrey, United KingdomJob Description · Are you a seasoned operations leader with a passion for healthcare looking to make a significant impact? · Position: Operations Director · Location: Flexible (between London and Birmingham) · As the Operations Director, you will play a critical role in driving ...
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Financial Director
2 days ago
Finatal Surrey, United KingdomJob Description · Finance Director · £120,000 per annum · Based in Surrey · JI49647 · A leading private equity investor has recently partnered with a multi-site business to execute a buy and build strategy. They are looking to take the business from 5 sites and £1 million EBIDTA ...
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Associate Director, Clinical Pharmacology
5 days ago
Haleon Surrey, United Kingdom Full timeHello. 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 global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren ...
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Regulatory/Risk & Compliance Assistant
14 hours ago
Setfords Surrey, United KingdomJob Description · Guildford · Permanent · Full Time · £31,000 - £35,000 per annum depending on experience · Who we are · We believe traditional law firms are outdated. Long hours and punishing billing targets mean that lawyers often don't have the time or capacity to do their bes ...
Director of Compliance - Surrey, United Kingdom - EPM Scientific
Description
The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.
DESCRIPTION OF THE ROLE
