Regulatory Affairs Associate

TN United Kingdom; Caerphilly; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a dedicated Regulatory Affairs Associate to join their team in Caerphilly. This role offers a hybrid working model, allowing you to balance your professional and personal life while contributing to impactful solutions in a highly regulated sector. You will support the RA Director in managing regulatory documentation, assist with submissions to competent authorities, and help create compliant procedures. If you are passionate about regulatory affairs and eager to grow your expertise in a dynamic environment, this opportunity could be the perfect fit for you.

Benefits

25 days holiday + Bank Holidays

5% Bonus

Company Pension

Training and development courses

Qualifications

• Experience in regulatory affairs within a highly regulated industry.
• Familiarity with technical files and competent authority regulations.

Responsibilities

• Support the RA Director with regulatory documentation and technical files.
• Compile vigilance PMS and PSUR reports for regulatory submissions.

Skills

Regulatory Affairs

Technical Documentation

Quality Management Systems

Education

Experience in Regulatory Affairs

Background in Medical or Pharmaceutical Industry

Job description

Social network you want to login/join with:

Regulatory Affairs Associate, Caerphilly

Client:

Hunter Selection

Location:

Caerphilly, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

7791c6ab59d6

Job Views:

42

Posted:

10.04.2025

Expiry Date:

25.05.2025

Job Description:

Regulatory Affairs Associate

Caerphilly CF83

• 25 days holiday + Bank Holidays
• 5% Bonus
• Company Pension
• Training and development courses

Are you passionate about delivering solutions to customers which deliver a genuine positive impact? This could be the perfect opportunity for you. My client is an international business with a strong market presence within their sector. They are looking to add a vital acquisition of a Regulatory Affairs Associate to the regulatory team. This role will provide you with a hybrid working model and the opportunity to develop your skillset within a highly regulated industry.

Roles and Responsibilities:

• Support RA Director for regulatory documentation including updating technical files, reports and procedures.
• Compile vigilance PMS and PSUR reports.
• Documentational support for world-wide regulatory submissions.
• Assist with Competent Authority registrations including the MHRA and ECREP.
• Create Declarations of Conformity.
• Review and manage standards database.
• Support Management of Patents and Trademarks.
• Create and implement compliant Regulatory procedures.

Requirements:

• The successful candidate will have experience working within regulatory affairs.
• The ideal background for this role would come from a highly regulated industry – medical, pharmaceutical.
• Experience of technical files, competent authority regulations.
• Experience working with quality management systems.

Suitable candidates should apply immediately by calling Jack Lavis for this vacancy – on 02920 894900 or by sending your CV directly to him.