Regulatory Affairs Manager
3 weeks ago
PE Global are currently recruiting for a Regulatory Affairs Manager (CTA) with EU experience for an initial 12 month contract role with a leading multinational Pharma client based in either Uxbridge or Cambridge - 1 day per month in the office.You will be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.Job Responsibilities• Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within our portfolio in compliance with global filing plans and local regulatory requirements. • Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements. • Provide content guidance for regional regulatory documents and meetings in accordance with global strategy • Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans) • Support regional label negotiation activities • Under general supervision participate in the development, and execution of regional regulatory product strategies • Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to our products. • Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. • Under supervision evaluate and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling.Requirements• EU experience• Scientific Degree and demonstrated experience in a similar role • Regulatory principles o Working with policies, procedures and SOP’s o Knowledge of legislation and regulations relating to medicinal products o Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals. • Knowledge of drug development • Knowledge of and experience in regional regulatory environment • Strong communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Ability to anticipate and prevent potential issues • Ability to resolve conflicts and develop a course of action leading to a beneficial outcomeInterested candidates should submit an up to date CV.***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***
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Regulatory Affairs Manager
2 weeks ago
Uxbridge, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the region and make sure that...
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Regulatory Affairs Manager
6 days ago
Uxbridge, United Kingdom Park Street People Full time £125 - £150Role OverviewAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and experience to join their team on a 12‑month temporary contract. The role works closely with the regulatory team and core stakeholders across multiple areas, providing regulatory strategy and guidance to ensure deadlines and...
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Regulatory Affairs Manager
2 weeks ago
Uxbridge, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on an initial 12-month contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
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Regulatory Affairs Manager
1 week ago
Uxbridge, United Kingdom CK GROUP Full timeCK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Uxbridge or Cambridge on a on a contract basis for 12 months.**Salary**: Hourly: £45.56 PAYE or £60.35 Umbrella**Company**: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by...
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Regulatory Affairs Manager Cmc
2 weeks ago
Uxbridge, United Kingdom PE Global Full time**PE Global is currently recruiting for a Regulatory Affairs Manager for a leading multi-national Biotech client based in Uxbridge with a hybrid work option.** **Role**: - Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more...
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Regulatory Affairs Senior Manager
1 week ago
Uxbridge, United Kingdom CK GROUP Full timeCK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company, who are based in Uxbridge and Cambridge on a contract basis for 6 months. This role is inside IR35, and allows for Remote working. **Rates**: Hourly: Up to £80 Umbrella **Company**: Our client is committed to unlocking the potential of biology for patients...
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Regulatory Affairs Manager
3 weeks ago
london (uxbridge), United Kingdom PE Global Full timePE Global are currently recruiting for a Regulatory Affairs Manager (CTA) with EU experience for an initial 12 month contract role with a leading multinational Pharma client based in either Uxbridge or Cambridge - 1 day per month in the office. You will be working with colleagues who are responsible for leading the European regulatory strategies and...
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Regulatory Affairs Associate
1 week ago
Uxbridge, United Kingdom Proclinical Full timeProclinical are recruiting for a Regulatory Affairs Associate to join a pharmaceutical organisation. This role is on a contract basis and is either located in Uxbridge or Cambridge. **Key Skills and Requirements**: - Familiarity in an administrative field within a corporate or similar setting preferably within a healthcare sector. - Educated to a degree...
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Senior Regulatory Affairs Manager EU Oncology
2 weeks ago
Uxbridge, United Kingdom Hays Careers Full timeSenior Regional Regulatory Affairs Lead - Oncology (EU Markets)Your new company Are you a seasoned regulatory affairs professional with a passion for oncology and a deep understanding of European regulatory frameworks? Our client, a leading global biopharmaceutical company, is seeking a Senior Regional Regulatory Affairs Lead to drive regulatory strategy and...
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Cmc Regulatory Affairs Associate
2 weeks ago
Uxbridge, United Kingdom Park Street People Full time**Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Associate to join their team in Uxbridge.** Working in a busy global department, there is a focus on working together to achieve results. You would be joining a company with an exciting pipeline who are continually developing their drug portfolio. This is a...
