Regulatory Documentation Scientist

2 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 of people. Their UK site is a key part of their global research and development programme.

**About the Job**
- Manages the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
- Leads Writing/Editing Team for preparation of Clinical Dossiers/Safety Reports
- Reviews documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product/ within a clinical dossier
- Prepares specifications for outsourced work (writing/review of documents) and serves as Roche liaison for project purposes
- Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planning and resourcing of all documents assigned to Writing/Editing Team including work to be outsourced
- Actively contributes to best practices and continuous improvement within Regulatory Documentation. Represents the group in functional and cross functional initiatives/projects when required
- Acts as a mentor to new members/less experienced members of the Documentation group

In addition, assumes the responsibilities of a Regulatory Documentation Scientist

Ideally: 5 years experience
- Demonstrated clear, high-quality scientific writing style in the English language
- Experience in regulatory affairs or related functions in drug development, knowledge of international regulations, and previous experience of authoring and/or editing regulatory documentation.
- Aptitude or proven ability to guide the work of others
- Ability to independently analyze and synthesize data from a broad range of disciplines
- Project management skills: consistently achieves multiple tasks and goals on-time
- Strong interpersonal and verbal communication skills
- Influencing skills: can influence without authority.

The company is offering a competitive salary as well as a supportive and inclusive culture, with a strong focus on employee development. Plus, you will be part of an amazing team
If this looks of interest and you meet the requirements, don’t miss this opportunity



  • Stevenage, Hertfordshire, United Kingdom Kenton Black Full time

    Senior Bioanalytical Scientist Coordinate sample analysis projects for various studies. Resolve technical and regulatory issues. Manage and lead laboratory personnel. Support Senior Management in optimizing procedures. PhD, MSc, or BSc in chemistry or related field. Excellent English proficiency. Solid scientific team with career growth...


  • 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...


  • 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...


  • Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    Site Name: UK - Hertfordshire - Stevenage, Baar Onyx, GSK House, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Are you interested in a leadership opportunity to bring ground-breaking cancer therapies to patients by working with a team that unites science, technology, and talent? The Clinical Scientist will report to the Clinical...

  • Safety Scientist

    1 week ago


    Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    Principal Scientist - Computational Science, Non-Clinical Safety The R&D Non-Clinical Safety (NCS) organisation has a focus on the application of cellular and molecular approaches to elucidate mechanisms of toxicity, understanding species differences, and identifying novel translational safety biomarkers to inform on project decisions. The NCS...


  • Stevenage, Hertfordshire, United Kingdom Kenton Black Full time

    Senior Bioanalytical Scientist Company: CRO – Bioanalytical Department Location: Cambridge / Stevenage Responsibilities: Develop LC-MS/MS methods for NCEs, peptides, and oligonucleotides. Troubleshooting LCMS instrument Validate LC-MS/MS methods for drug quantification. Coordinate sample analysis projects for various studies. Communicate...


  • Stevenage, Hertfordshire, United Kingdom Energy Jobline CVL Full time

    Senior Bioanalytical Scientist Company: CRO – Bioanalytical Department Location: Cambridge / Stevenage Responsibilities: Develop LC-MS/MS methods for NCEs, peptides, and oligonucleotides. Troubleshooting LCMS instrument Validate LC-MS/MS methods for drug quantification. Coordinate sample analysis projects for various studies. Communicate effectively with...


  • 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...

  • Medical Device Regulatory Affairs Specialist

    Found in: Jooble UK C2 - 5 days ago


    Royston, Hertfordshire, United Kingdom Vector Recruitment Ltd 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...


  • Stevenage, Hertfordshire, United Kingdom ATMP Ltd. Full time

    This site uses third-party website tracking technologies to provide and continually improve our services, and to display advertisements according to users' interests. I agree and may revoke or change my consent at any time with effect for the future. Downstream Processing Scientist page is loaded Downstream Processing Scientist Apply locations Stevenage,...


  • Hertfordshire, United Kingdom Currys Full time

    We are Currys. One team with one big passion. Technology. We sell it, we deliver it, we install it, we support it, we fix it. And, most important of all, we bring a human touch to tech to make the magic happen! As the UKs best-known retailer in tech, we are very proud of the service levels we provide for our customers. Online, in-store or in their homes, we...

  • Regulatory Compliance Manager

    Found in: Jooble UK C2 - 3 weeks ago


    Stevenage, Hertfordshire, United Kingdom Currys Full time

    We are Currys. One team with one big passion. Technology. We sell it, we deliver it, we install it, we support it, we fix it. And, most important of all, we bring a human touch to tech to make the magic happen! As the UKs best-known retailer in tech, we are very proud of the service levels we provide for our customers. Online, in-store or in their homes, we...


  • Stevenage, Hertfordshire, United Kingdom Currys Full time

    We are Currys. One team with one big passion. Technology. We sell it, we deliver it, we install it, we support it, we fix it. And, most important of all, we bring a human touch to tech to make the magic happen! As the UKs best-known retailer in tech, we are very proud of the service levels we provide for our customers. Online, in-store or in their homes, we...

  • Senior Manager/Director of Regulatory Affairs

    Found in: Jooble UK C2 - 3 weeks ago


    Stevenage, Hertfordshire, United Kingdom Currys Full time

    We are Currys. Technology. We sell it, we deliver it, we install it, we support it, we fix it. And, most important of all, we bring a human touch to tech to make the magic happen! As the UKs best-known retailer in tech, we are very proud of the service levels we provide for our customers. Online, in-store or in their homes, we go the extra mile. Regulatory...


  • Stevenage, Hertfordshire, United Kingdom Currys Full time

    We are Currys. Technology. We sell it, we deliver it, we install it, we support it, we fix it. And, most important of all, we bring a human touch to tech to make the magic happen! As the UKs best-known retailer in tech, we are very proud of the service levels we provide for our customers. Online, in-store or in their homes, we go the extra mile. Regulatory...


  • 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...


  • Stevenage, Hertfordshire, United Kingdom Kenton Black Ltd Full time

    Coordinate sample analysis projects for various studies. Resolve technical and regulatory issues. Manage and lead laboratory personnel. Support Senior Management in optimizing procedures. PhD, MSc, or BSc in chemistry or related field. Solid scientific team with career growth opportunities.


  • 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...


  • Stevenage, Hertfordshire, United Kingdom Kenton Black Ltd Full time

    Develop LC-MS/MS methods for NCEs, peptides, and oligonucleotides. Troubleshooting LCMS instrument Coordinate sample analysis projects for various studies. Communicate effectively with sponsors for timely results. Resolve technical and regulatory issues. Manage and lead laboratory personnel. Support Senior Management in optimizing procedures. Profile...

  • Labelling Hub

    1 week ago


    Hertfordshire, United Kingdom Quanta Full time

    Labelling Hub - Pharmaceuticals - Hertfordshire Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland’s picturesque capital? Our esteemed client is looking for a Labelling Hub to join their team in their existing manufacturing facility in Hertfordshire. The facility is a responsible for tablet manufacturing...