We are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area.
As the Regulatory Affairs Officer, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications.
Your expertise will be instrumental in writing, compiling, and publishing dossiers for UK National & EU submissions, ensuring compliance with regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1.
Oversee dossier compilation and submission for UK and EU markets.
2.
Liaise with regulatory bodies and manage communication regarding variations.
3.
Develop product information and approve artwork for regulatory compliance.
4.
Ensure that CMC practices align with regulatory standards, developing clear justifications for new product licenses and variations.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Regulatory Affairs Officer, we are looking to identify the following on your profile and past history:
1.
Educated to degree level in science or equivalent experience.
2.
Proven experience in Regulatory Affairs within the Pharmaceutical industry.
3.
Strong communication and project management skills.
4.
Proficiency in MS Office suite and regulatory submission portals.
Key Words: Regulatory Affairs Officer | Pharmaceutical | Life Cycle Management | CMC | Clinical | Safety | Product Information | Dossier | Submission | Variations | MA Transfer | eCTD | EMC | MHRA | CESP | Pharmacovigilance |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer.
We welcome applications for any applicant who fulfils the role requirements for this position.
HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists.
We look forward to helping you with your next career moves. ....Read more...
Type: Permanent Location: Kent,England
Start: 12/06/2024
Salary / Rate: Competitive
Posted: 2024-06-12 09:08:06
Are you a Biomedical Scientist seeking a new challenge? Do you have a passion for Haematology?Service Care Solutions are working with University Hospitals of Derby & Burton NHS Foundation Trust to recruit a Band 6 Biomedical Scientist to support a The Haematology Team in the Derbyshire area.
The successful candidate will primarily work and provide support with FBC and Coagulation analysis.The contract duration is for 3 months with the likelihood of extension.
This is a full-time placement with 37.5 hours available.
Part-time applications of 3 Days or more will also be considered.
Shifts: Monday to Friday, 09:00 - 17:00Location: DerbyshirePay: £25.00 p/h LTDBonus: £250 Sign-Up BonusJob Purpose - Band 6 Haematologist Key Responsibilities:
Diagnostic Testing: Conduct haematological tests using Sysmex XN FBC and Werfen coagulation analysers.
Quality Control: Ensure accuracy of test results through strict quality control procedures and participate in audits.
Data Analysis: Analyse test results, report abnormalities, and communicate critical values to clinical teams.
Equipment Maintenance: Perform routine maintenance and troubleshooting of laboratory equipment.
Sample Management: Handle, label, and store patient samples according to protocols.
Record Keeping: Maintain detailed and accurate records of tests and update patient records and lab information systems.
Team Collaboration: Work with biomedical scientists, lab technicians, and clinicians, providing expert advice on test results.
Training: Engage in professional development and assist in training junior staff and students.
Health and Safety: Comply with health and safety regulations, using PPE and ensuring proper disposal of hazardous materials.
Requirements
IBMS Accredited degree
HCPC Registration
Experience using Sysmex XN FBC analysers and Werfen coagulation analysers
Benefits
Four weekly payroll runs
£250 training allowance
Excellent pay rates
Exceptional referral bonuses
Specialists mental health consultants offering single point of contact
Frequent notifications for upcoming opportunities via text and email
Ltd & PAYE payment options available
Nationwide provider of mental health staff to over 40 different NHS trusts offering mental health services and over 200 local authorities.
FREE DBS disclosures provided via fast track online services
FREE Occupational Health Check and Immunisations
Are you happy with your current agency? At SCS, we believe in rewarding your loyalty and hard-work!
£150 Agency Switch Bonus - Service Care Solutions will give you £150 for bringing your current contract to us.
£250 Welcome Bonus - We are offering a Welcome Bonus of £250, paid after completion of 150 hours in your new placement.
£750 Referral Bonus - Simply refer your friend.
If they get the role, we'll give you up to £750.
....Read more...
Type: Contract Location: Burton-On-Trent, England
Salary / Rate: Up to £25 per hour + £250 bonus
Posted: 2024-05-31 14:22:10
