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For Companies At a Glance
- Tasks: Lead compliance reviews and educate staff on regulatory requirements.
- Company: Join Almac Group, a global leader in advancing human health through innovative drug development services.
- Benefits: Enjoy flexible working hours and opportunities for international travel after probation.
- Why this job: Make a real impact in healthcare while working in a dynamic and supportive environment.
- Qualifications: Must have a degree in a scientific discipline and knowledge of GMP regulations.
- Other info: This role requires a proactive approach and offers a chance to work with top pharmaceutical companies.
The predicted salary is between 36000 - 60000 £ per year.
Almac Group is a global leader in advancing human health. We provide a range of expert services across the drug development lifecycle to pharmaceutical and biotech companies, supporting them in finding treatments for patients.
Skills and Attributes
- Supervisory experience
- Knowledge of GMP
- Investigational Medicinal Products
Description
Regulatory Compliance Manager
Hours: 37.5 hours per week
Business Unit : Clinical Services
Open To : Internal and External Applicants
Ref No.: HRJOB10420
The Role
The Regulatory Compliance Manager is responsible for the proactive review and assessment of forthcoming or recent regulatory changes to ascertain requirements and determine any necessary actions to ensure continued compliance. In doing so, they will support department managers in the facilitation of Change Control and Risk Assessment to ensure the smooth implementation of changes in line with agreed timelines.
The Regulatory Compliance Manager also plays a key role in educating staff of the regulatory requirements they must comply with in order to recognize potential non-compliances and ensure new systems and processes are compliant. This proactive approach safeguards quality and helps ensure project timelines are met.
Furthermore, the role involves preparing and cascading regular newsletters, training materials, escalating issues or concerns, and providing support during investigations, serving as a key point of contact for customers, regulatory agencies, and pharmaceutical forums regarding queries related to new regulations.
Key Requirements
- Have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full-time employment in the UK
- Knowledge of GMP and current regulations
- Degree in a scientific discipline
- Regulatory knowledge of Investigational Medicinal Products
- Technical knowledge of Operational activities (production and distribution) undertaken by Almac Clinical Services
- Experience within a supervisory role
- Experience in Change Control and Risk Assessments
Further Information
After a successful probation period, the working pattern for this role is a flex pattern between the hours of 06:00 – 22:00 with a requirement of 5 hours minimum per day.
This role will require coverage beyond normal working hours and international travel as and when required.
Apply Now
Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.
Closing Date
We will no longer be accepting applications after 5pm on 25 February 2025 .
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group is an Equal Opportunity Employer.
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Regulatory Compliance Manager employer: OASIS Group
Contact Detail:
OASIS Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Compliance Manager
✨Tip Number 1
Familiarize yourself with the latest GMP regulations and Investigational Medicinal Products. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory compliance field. Attend industry conferences or webinars to connect with others and learn about best practices, which can give you an edge during the application process.
✨Tip Number 3
Prepare to discuss your supervisory experience in detail. Think of specific examples where you successfully managed teams or projects, especially in relation to change control and risk assessments.
✨Tip Number 4
Be ready to showcase your communication skills. As a Regulatory Compliance Manager, you'll need to educate staff and liaise with various stakeholders, so practice articulating complex regulatory concepts clearly.
We think you need these skills to ace Regulatory Compliance Manager
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Regulatory Compliance Manager position. Make sure you understand the key responsibilities and requirements, especially regarding GMP and Investigational Medicinal Products.
Tailor Your CV: Customize your CV to highlight your relevant experience and skills that align with the job criteria. Emphasize your supervisory experience, knowledge of regulatory compliance, and any specific achievements in Change Control and Risk Assessments.
Craft a Strong Cover Letter: Write a compelling cover letter that explains why you are a great fit for the role. Use specific examples from your past experiences to demonstrate your understanding of regulatory requirements and your proactive approach to compliance.
Submit Your Application: Once your CV and cover letter are ready, submit your application through the StudySmarter website. Ensure that all documents are in PDF format and double-check for any errors before hitting 'submit'.
How to prepare for a job interview at OASIS Group
✨Show Your Regulatory Knowledge
Make sure to brush up on your knowledge of GMP and current regulations. Be prepared to discuss how these regulations impact the role and how you can ensure compliance within the organization.
✨Demonstrate Supervisory Experience
Highlight your previous supervisory roles and how you've successfully managed teams. Share specific examples of how you've facilitated Change Control and Risk Assessments in past positions.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in regulatory compliance. Think about past challenges you've faced and how you navigated them to maintain compliance.
✨Communicate Clearly and Confidently
As a key point of contact for various stakeholders, strong communication skills are essential. Practice articulating your thoughts clearly and confidently, especially when discussing complex regulatory topics.
