Interim Regulatory Affairs Manager
2 weeks ago
Interim Regulatory Affairs Manager
Walker Cole International, a modern search company based in the UK, are currently working with an exciting global speciality pharmaceutical company that is currently recruiting for an interim Regulatory Affairs Manager to join the business on a 6 to 12 monthcontract basis (outside IR35). The business are an innovative business with a portfolio of products in the rare-disease category. The business offer a flexible hybrid working policy, with time in the office and working from home.
As the Interim Regulatory Affairs Manager you will be responsible for all lifecycle maintenance activities across the product portfolio for the business and support the team.
The main responsibilities will include:
- Develop Regulatory strategies for innovative and rapid access to new markets
- Manage routine Manufacturing Authorisation (MA) maintenance activities for National and MRP procedures including compilation and submission of variations and renewals
- Ensure submissions of Marketing Authorisation Applications (MAAs) in European and Global territories can be successful
- Significant experience in the pharmaceutical industry ideally with rare disease capabilities
- Strong knowledge of EU Regulations
- Proven experience in EU Regulatory Affairs within either an R&D or Established product environment
-
Regulatory Affairs and Quality Manager
1 week ago
South East England, United Kingdom Page Group Full timeThe local role is essential for Scientific Affairs to stay close to its most important stakeholders: the customers, patients, consumers and HCPs. **Client Details** My Client is a fast growing pharmaceutical business who own and commericialize branded, orginial over the counter products and prescription medicinies. Products are available in more than 60...
-
Senior Regulatory Affairs Officer
5 days ago
South East England, United Kingdom WALKER COLE INTERNATIONAL LTD Full timeYou will be responsible for: - Liaising with both internal and external stakeholders to ensure all regulatory requirements are met. - Co-ordinating and submitting PSURs and preparing responses to questions from Regulatory Authorities. - Monitoring product safety information, maintaining product labelling and reviewing artworks for use in submissions. - At...
-
Senior Manager Regulatory Affairs
2 weeks ago
North East, United Kingdom Kinetica Full timeKinetica Tyne And Wear, England, United Kingdom Senior Manager Regulatory Affairs We are looking for a highly regulatory Manager with experience in 510K submissions, PMA and leading senior/experienced team. This is a fully site-based role with an expected 15% travel. Responsibilities Lead and mentor an experienced Regulatory Affairs team responsible for...
-
Senior Manager Regulatory Affairs
2 weeks ago
Tyne And Wear, England, United Kingdom Kinetica Full time £60,000 - £100,000 per yearSenior RA Manager – NE/ Tyne & Wear– DiagnosticsAbout the Company:We are looking for a highly regulatory Manager with experience in 510K submissions, PMA and leading senior/experienced team. This is a fully site-based role with an expected 15% travel.Responsibilities:Lead and mentor an experienced Regulatory Affairs team responsible for global...
-
Regulatory Affairs Consultant
1 week ago
Uxbridge, England, United Kingdom Parexel Full time £70,000 - £110,000 per yearAbout The RoleWe are seeking an experienced Regulatory Affairs professional specializing on in vitro diagnostics (IVD) and Companion Diagnostics (CDx) to join our Global Regulatory Affairs team. In this strategic role, you will provide expert guidance on regulatory pathways for IVD and CDx development, clinical trials, and marketing authorizations while...
-
Global Regulatory Affairs Specialist: FDA
2 weeks ago
South Yorkshire, United Kingdom Aurora Lifesciences Full timeA medical device company in South Yorkshire is seeking a Regulatory Affairs Specialist to support global regulatory strategies and ensure compliance with FDA and EU MDR frameworks. The role involves managing regulatory filings, ensuring compliance, and collaborating across teams. The ideal candidate will have 3–5 years of regulatory affairs experience in...
-
Regulatory Affairs Consultant
1 week ago
Uxbridge, England, United Kingdom Parexel Full time £50,000 - £90,000 per yearAbout The RoleWe are seeking an experienced Regulatory Affairs professional to lead our medical devices and combination products clinical trial regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways for clinical investigations and serve as the key regulatory representative for our global project teams.The role can...
-
Regulatory Operations Manager
2 weeks ago
South East England, United Kingdom Page Group Full timeExciting opportunity to join a fast growing biotech in a pivotal point of growth. **Client Details** I have partnered with a fast growing biotech businesses based in the south who are growing significantly. Due to growth they are looking for a Regulatory Operations Manager - PART TIME to join the team. **Description** Reporting to the Regulatory Affairs...
-
Senior Regulatory Affairs Manager EU Oncology
4 weeks ago
England, United Kingdom Hays 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...
-
Regulatory Affairs Specialist
3 days ago
Newquay, England, United Kingdom Cytiva Full time £40,000 - £70,000 per yearBe part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...