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- Tasks: Ensure compliance with regulatory standards in the pharmaceutical industry and manage documentation.
- Company: Join a leading client in the pharmaceuticals sector focused on safety and quality.
- Benefits: Enjoy 20 days holiday plus 8 bank holidays, with flexible working hours.
- Why this job: Be part of a vital role ensuring product safety and quality while gaining valuable experience.
- Qualifications: Experience in highly regulated industries is preferred; attention to detail is essential.
- Other info: Opportunity for additional hours and ad-hoc duties as needed.
The predicted salary is between 29000 - 32000 £ per year.
Overall Objective: We are recruiting on behalf of a client for Regulatory Assurance Officer.
Salary: £29,000 to £32,000
Location: Walsall
Working Hours: Monday to Thursday 8am - 5pm, Friday 8am - 12pm
Holidays: 20 days plus 8 Bank Holidays
Sector: Pharmaceuticals, we are open to candidates who have experience working in highly regulated industries.
You will work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
Duties and Responsibilities:
- Preparation of Raw Product Specification: New set up. Changing in import packaging (Outer pack, inner pack imported leaflet, any additional devices/components included in import packaging). Licence taken off No Process. Licence taken off Suspended. Variation granted.
- Preparation of Material Specification: New set up. Licence taken off No Process. Licence taken off Suspended. Variation granted (e.g., PIL).
- Preparation of Master Packaging Record: New set up. Licence taken off No Process. Licence taken off Suspended. Variation granted (e.g., PIL).
- Ensuring artwork template approval is carried out prior to external printing components.
- Ensuring superseded version of components are sent for destruction.
- Documentation Control and Archiving: Ensuring superseded versions of documents are removed for use. Ensuring documentation for licence(s) on No Process or Suspended are removed for use. Ensuring Component Specifications and master BPRs for licences due to PIL update are removed for use. Ensuring master BPR electronically removed for use due to update. Ensuring updated labels are moved to live folder for production use and old labels are removed for use. Ensuring correct version of PIL available for production and old versions are removed for use.
- Creating repack link requested by production.
- Maintaining QF spreadsheet, Master Batch Packaging spreadsheet.
- Informing production of any inconsistencies.
- Raising quality incident if needed.
- Partially conducting Bollino / Vignette authenticity checks as part of RPS preparation.
- Informing regulatory about product ID failures and booking off samples from stock as required.
- Notifying the relevant departments to send surplus samples for destruction.
Other duties:
- Ad-hoc duties as they arise and when needed.
- Additional hours are worked as required to suit business needs.
- Reporting any issues and any concerns regarding Health and Safety to Line Manager.
- Compliance with GDP/GMP.
- Attend all mandatory trainings (e.g. Health and Safety).
Regulatory Assurance Officer employer: McAllister Recruitment & Consultancy
Contact Detail:
McAllister Recruitment & Consultancy Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Assurance Officer
✨Tip Number 1
Familiarise yourself with the specific regulations and standards in the pharmaceutical industry. Understanding the nuances of compliance, GDP, and GMP will not only boost your confidence but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals already working in regulatory roles within pharmaceuticals. Attend industry events or join relevant online forums to gain insights and potentially get referrals that could help you land the job.
✨Tip Number 3
Prepare to discuss your experience in documentation control and archiving during interviews. Be ready to provide examples of how you've managed similar tasks in previous roles, as this is crucial for the position.
✨Tip Number 4
Showcase your attention to detail and problem-solving skills. Prepare scenarios where you've identified inconsistencies or raised quality incidents, as these are key responsibilities of a Regulatory Assurance Officer.
We think you need these skills to ace Regulatory Assurance Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory assurance or similar roles within highly regulated industries, such as pharmaceuticals. Use keywords from the job description to demonstrate your fit for the position.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the responsibilities listed in the job description. Explain how your previous experiences align with the duties of the Regulatory Assurance Officer and express your enthusiasm for the role.
Highlight Compliance Knowledge: Emphasise your understanding of compliance with GDP/GMP regulations in your application. Mention any specific training or certifications you have that relate to quality assurance and regulatory standards.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a role in regulatory assurance.
How to prepare for a job interview at McAllister Recruitment & Consultancy
✨Understand Regulatory Standards
Familiarise yourself with the key regulatory standards relevant to the pharmaceutical industry. Be prepared to discuss how you have ensured compliance in previous roles, as this will demonstrate your understanding of the importance of regulations in maintaining product safety and quality.
✨Showcase Attention to Detail
Given the nature of the role, attention to detail is crucial. Prepare examples from your past experiences where your meticulousness has led to successful outcomes, especially in documentation control or quality assurance tasks.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in a regulatory context. Think about potential challenges you might face in the role and how you would address them, particularly regarding documentation and compliance issues.
✨Demonstrate Team Collaboration Skills
The role requires working effectively with various departments. Be ready to share examples of how you've successfully collaborated with others in past positions, highlighting your communication skills and ability to work towards common goals.
