- Lead/support all CTR initial submissions, transitions, amendments, and re-submissions
- Prepare all CTR-related documentation and be responsible for uploading this to the CTIS portal
- Act as an SME for the CTIS portal advising on how to use this system
- Participate in EU-CTR consulting and contributing to its operational implementation
- Drive EU CTR submissions, amendments, and strategies
- Provide leadership and expertise in regulatory and submissions-related aspects of clinical trials
- Offer guidance on submissions expertise to junior team members
- Facilitate transversal collaboration between departments for the timely delivery of all submissions of complex large clinical trials
- A degree in a scientific discipline
- Background in clinical trial management
- Experience in Regulatory Affairs
- Good level of knowledge of Clinical Trial Submissions on a local and regional level
- Working knowledge of submissions under EU-CTR directive
- Solution-oriented and problem-solving skills
- Customer-oriented and able to work in a team as well as autonomously
- Fluent in English is a must (written and spoken)
-
Regulatory Affairs Consultant
4 days ago
Cpl Life Sciences Slough, Berkshire, United Kingdom £65 - £75Job Title: Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35) · Job Type: 12-month contract · Location: Berkshire, UK – Hybrid · Pay Rate: £65-75 per hour (PAYE) · We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulat ...
-
Regulatory Affairs Consultant
3 weeks ago
Cpl Life Sciences Slough, United KingdomJob Title: · Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35)nJob Type: · 12-month · contractnLocation: · Berkshire, UK – HybridnPay Rate: · £65-75 per hour (PAYE) · We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulat ...
-
Regulatory Affairs Consultant
3 weeks ago
Cpl Life Sciences Slough, United KingdomJob Title: Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35) · Job Type: 12-month contract · Location: Berkshire, UK – Hybrid · Pay Rate: £65-75 per hour (PAYE) · We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulat ...
-
Regulatory Affairs Consultant
3 weeks ago
Cpl Life Sciences Slough, United KingdomJob DescriptionJob Title: Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35) · Job Type: 12-month contract · Location: Berkshire, UK – Hybrid · Pay Rate: £65-75 per hour (PAYE) · We are partnered with a leading Pharmaceutical organization who are looking for an experi ...
-
Regulatory Affairs Consultant
1 week ago
Cpl Life Sciences Slough, Berkshire, United Kingdom £65 - £75Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35) · contract · Berkshire, UK - Hybrid · 65-75 per hour (PAYE) · We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis. Yo ...
-
Regulatory Affairs Consultant
1 week ago
Cpl Life Sciences Slough, Berkshire, United Kingdom £65 - £75Job Title: · Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. · Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35) · Job Type: · 12-month · contract · Location: · Berkshire, UK – Hybrid · Pay Rate: ...
-
Regulatory Affairs Consultant
1 week ago
IMC LOCUMS LIMITED Hertfordshire, United Kingdom**Job description** My client are a highly successful Regulatory Affairs Consulting Practice. They serve the Pharmaceutical and Biotechnology industries, from early stage product development through to marketing approval. They have a great culture, excellent values, a verysupport ...
-
Regulatory Affairs Consultant
2 weeks ago
RNI Consulting London, United Kingdom**COMPANY DESCRIPTION** · For over 16 years, our consulting firm has been helping companies in the food, nutrition, pharmaceutical, medical device, and cosmetics industries to develop their business in the UK, USA, Europe and abroad. Our team of 15 full-time consultants are sprea ...
-
Regulatory Affairs Consultant
3 weeks ago
IMC Life Sciences London, United KingdomWould you like to RELOCATE to the NETHERLANDS? Sound like the dream? · My client, a highly successful Regulatory Affairs Consulting Practice serving Pharmaceutical and Biotechnology clients, from early stage development up to marketing approval, are looking to hire a Regulatory A ...
-
Senior Regulatory Affairs Consultant
2 days ago
Parexel Uxbridge, United Kingdom Full timeWhen our values align, there's no limit to what we can achieve. · We are looking for a Senior Consultant Regulatory Affairs for Labelling . This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will pa ...
-
Regulatory Affairs Consultant
1 week ago
Blackfield Associates Greater London, United KingdomMy client, a Bio-therapeutic business based in Greater London, has defined the duties as: · - Preparation of reg affairs for MHRA inspection · - Support for ROW/EU to allow full time members of team to focus on regulatory strategy and regulatory inspection preparation. · - Part o ...
-
Corporate Affairs Consultant
5 days ago
f1 recruitment London, United KingdomCorporate Affairs Consultant · Are you a corporate affairs candidate, looking to join leading strategic communication consultancies and be part of their ever-growing offerings? · At f1 recruitment, we are working with consultancies across the UK, Europe and the Middle East, cov ...
-
Public Affairs Consultant
2 weeks ago
f1 Recruitment Limited london, United KingdomSenior Public Affairs Consultant · Are you a public affairs candidate, looking to join leading strategic communication consultancies and be part of their ever-growing offerings? · We are currently working with one of Londons fastest growing communications firms who are currenlty ...
-
Regulatory Affairs Consultant
3 weeks ago
Lifelancer London, United KingdomRegulatory AffairsConsultant. · 8years experience in handling life cycle management of approved drugproducts (like tablets (oral solids) syrups (oral liquids)parenterals (injections/ injectables for EUmarket. · Good understanding of regulatoryframework including regional trends f ...
-
Regulatory Affairs Consultant
4 days ago
Michael Page (UK) England, United KingdomOur client is a fast growing medical devices consultancy, specialising in regulatory compliance, patents, clinical investigation and market entry. · Ensure compliance with all relevant regulatory standards and guidelines within the healthcare industry. · Develop and implement R ...
-
Regulatory Affairs Consultant
2 days ago
Clinical Professionals Limited London, United KingdomSenior Regulatory Affairs Labelling Consultant · Job Type: Permanent · Job Title: Senior Regulatory Labelling Consultant (Labelling Strategy) · Location: UK and Europe – Fully Remote · Salary: Competitive Salary + Excellent Benefits · Employee Type: Permanent · You will work ...
-
International Affairs Consultant
4 days ago
CENTRIK GLOBAL CONSULTING LIMITED London, United KingdomAbout Us: · Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. · Centrik is a leading global consulting firm dedicated to addressing the diverse needs of organizations in an era marked by conti ...
-
Regulatory Affairs Consultant
1 week ago
Lifelancer Ltd London, United KingdomRegulatory Affairs Consultant. · ~8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market. · ~ Good understanding of regulatory framework, including ...
-
International Affairs Consultant Remote
3 weeks ago
CENTRIK GLOBAL CONSULTING LIMITED London, United KingdomAboutUs: · Centrik is a leading globalconsulting firm dedicated to addressing the diverse needs oforganizations in an era marked by continual risk evolution andheightened connectivity. Our unwavering commitment lies inassisting clients in acquiring invaluable insights facilitatin ...
-
Consultant - Government & Corporate Affairs
3 weeks ago
Hasson Associates Recruitment Ltd London, United Kingdom Full timeThe Company:A leading market research company which blends insight, strategy and imagination together in one consultancy, working across a range of interesting and high-profile public and private sector clients · The Opportunity:Working in the Government and Corporate Affairs tea ...
Regulatory Affairs Consultant - Slough, United Kingdom - Cpl Life Sciences
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Job Title: Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35)
Are you the right candidate for this opportunity Make sure to read the full description below.Job Type: 12-monthcontract
Location: Berkshire, UK – Hybrid
Pay Rate: £65-75 per hour (PAYE)
We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis. You will work as a Regulatory EU CTR SME and support several EU CTR submissions.
As a Regulatory Affairs Professional, you will assume a crucial role in providing leadership and expertise in all regulatory and submission-related aspects of clinical trials. You will serve as the main point of contact and be responsible for delivering submission-specific milestones while offering guidance on submission strategies. Additionally, you will actively participate in EU-CTR consulting and contribute to the operational implementation aspects of the EU-CTR directive, ensuring effective collaboration between departments. Your role may also involve serving as a Clinical Trial Submission Coordinator/Lead, overseeing complex large clinical trial submissions.
Responsibilities:
Skills and Experience required:
You must be able to be based on site 3x a week in Berkshire, UK, and have the FULL right to work in the UK. For more information or to apply please reach out to