Regulatory Document Specialist Lead
5 days ago
We are currently looking for a Senior/Principal Medical Writer to join our team in the UK. As a key member of our clinical development team, you will be responsible for producing high-quality regulatory documents for the international pharmaceutical industry.
About the Role:
- You will prepare a variety of clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures, as the lead writer in collaboration with client authoring teams.
- You will ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of our clients.
- You will provide document-specific advice to clients and oversee other writers and QC specialists assisting on documents under your responsibility.
Requirements:
- At least 3 years of experience actively writing regulatory documents.
- Experience as the lead writer on at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs.
- For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers.
- Excellent communication skills and the ability to interact directly with clients or authors of documents.
- Competency in the use of document management systems and review tools.
What We Offer:
- A competitive salary of $90,000 - $120,000 per annum, depending on experience.
- The opportunity to work on a wide range of projects and develop your skills and expertise.
- A dynamic and supportive team environment.
-
Regulatory Document Specialist
3 days ago
Cambridge, Cambridgeshire, United Kingdom Vivify Talent Limited Full timeWelcome to Vivify Talent LimitedWe're a small consultancy with big ambitions, seeking an experienced Regulatory Document Specialist to spearhead key documents and projects. As a fully remote role, you'll enjoy autonomy and flexibility while collaborating with our passionate team.Your Key ResponsibilitiesDevelop top-tier regulatory documents, ensuring...
-
Regulatory Documentation Specialist
1 week ago
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeJob SummaryWe are seeking a highly experienced Regulatory Documentation Specialist to join our team at Lifelancer. As a Senior/Principal Medical Writer, you will play a crucial role in producing high-quality regulatory documentation for the international pharmaceutical industry.Key ResponsibilitiesPrepare clinical regulatory documents, including Clinical...
-
Scientific Document Specialist
2 days ago
Cambridge, Cambridgeshire, United Kingdom Costello Medical Full timeCostello Medical is a leading global healthcare agency specializing in medical communications, market access, and health economic and outcomes research. We are currently seeking a skilled Scientific Document Specialist to join our team.In this role, you will be responsible for developing high-quality scientific documents, including literature reviews,...
-
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeCpl Life Sciences is seeking a highly experienced Lead Regulatory Affairs Specialist to join our team in Cambridge, UK. This is a unique opportunity to work with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities.The successful candidate...
-
Regulatory Affairs Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeRegulatory Affairs SpecialistWe are expanding our Clinical Trial Submissions (CTS) group and are seeking an experienced Regulatory Affairs professional to join our team. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions. You'll have the opportunity to work under a generous,...
-
Regulatory Affairs Specialist
1 month ago
Cambridge, Cambridgeshire, United Kingdom Philips International Full timeJob SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Philips International. In this role, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for US, EU, and RoW.Your Key Responsibilities:Develop and execute...
-
Regulatory Affairs Specialist
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Vectura Group Full timeRegulatory LeadershipVectura Group, a global leader in inhaled therapies and drug-device combination products, seeks a seasoned Regulatory Affairs Manager to drive the success of our medical device and DDCP regulatory activities.Regulatory Expertise: Lead regulatory activities across Vectura Group, specializing in medical devices and DDCPs, to support...
-
Regulatory Affairs Specialist
1 month ago
Cambridge, Cambridgeshire, United Kingdom https:jobs-redefined.cositemap Full timeSenior Regulatory Scientist (Clinical Trial Submissions)We are expanding our Clinical Trial Submissions (CTS) group and are seeking an experienced Regulatory Affairs professional to support our team. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.As part of a supportive...
-
Regulatory Affairs Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeRole Overview:We are seeking a highly skilled Regulatory Affairs professional to join our Clinical Trial Submissions (CTS) group at VCLS. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.As part of a supportive and collaborative team, you'll play a key role in driving...
-
Regulatory Affairs Specialist
4 days ago
Cambridge, Cambridgeshire, United Kingdom Vectura Group Full timeJob SummaryWe are seeking a skilled Regulatory Affairs Specialist to join our team at Vectura Group. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with global regulations and guidelines for medical devices and drug-device combination products.Key Responsibilities:Lead regulatory activities across...
-
Regulatory Affairs Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeAbout the RoleProductLife Group is seeking a highly skilled Regulatory Affairs Specialist to join our team in the United Kingdom. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to support our clients in the UK and EU markets.Key ResponsibilitiesProvide guidance and support to...
-
Global Regulatory Affairs Specialist, Virology
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full timeJob DescriptionAt Gilead Sciences, we're dedicated to creating innovative therapies that improve lives worldwide. Our team of experts is passionate about tackling complex diseases, and we're seeking talented individuals to join our mission.Function:Global Therapeutic Area (TA) Regulatory Affairs, VirologyPosition Overview:As a Regional Regulatory Lead,...
-
Regulatory Compliance Specialist
4 days ago
Cambridge, Cambridgeshire, United Kingdom MRA Search Full timeOverviewMRA Search has been appointed by a rapidly expanding, Hong Kong-based asset management company to find a highly skilled Regulatory Compliance Specialist for their Cambridge office. This will be the firm's first UK Compliance hire and will suit candidates with a strong interest in crypto/web3.SalaryThe salary for this position is estimated to be...
-
Cambridge, Cambridgeshire, United Kingdom SAGENTIA Full timeAbout the RoleSagentia Innovation is seeking a skilled Regulatory Affairs Specialist to support our Human Factors compliance offering within the Medical Sector. As a key member of our team, you will work closely with our Head of Human Factors to develop and implement Human Factors/Usability Engineering Files and use-related risk documentation, ensuring best...
-
Regulatory Affairs Professional
4 days ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeAbout the JobIn a continuous effort to grow and expand our services, ProductLife Group is looking for a Regulatory Affairs Specialist to join our team in the United Kingdom.This position plays a vital role in developing our local UK Regulatory Affairs presence, overseeing new regulatory activities related to the UK for multiple clients. You will work closely...
-
Regulatory Affairs Specialist
4 days ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeVCLS is seeking a highly skilled Regulatory Affairs Specialist to drive forward regulatory processes, ensure compliance, and contribute to innovative clinical trials. The ideal candidate will have 4+ years of experience in Regulatory Affairs, with a focus on Clinical Trial Submissions (CTS). They will possess a deep understanding of regional and local...
-
Cambridge, Cambridgeshire, United Kingdom Hologic, Inc. Full timeAt Hologic, Inc., we are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team. As a leading innovator of women's health, we empower people to live healthier lives everywhere, every day.Our quality and regulatory affairs team is responsible for staying up-to-date on new, changing, and existing regulatory requirements....
-
Global Regulatory Affairs Labeling Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Title: Global Regulatory Affairs Labeling DirectorJob Summary:Gilead Sciences International, Ltd. is seeking a highly experienced Global Regulatory Affairs Labeling Director to lead our Global Regulatory Affairs Labeling organization. The successful candidate will be responsible for developing and implementing global labeling strategies, ensuring...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full timeJob DescriptionGilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. We're tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to develop therapies that improve lives and ensure access to these therapies across the globe.As a key member of our team, you'll play a...
-
Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000**Regulatory Affairs Director Role Overview**Cpl Life Sciences is seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy and drive business growth.As a key member of our team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and guidelines.**Key...