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- Tasks: Ensure regulatory compliance for pharmaceuticals and medical devices across various markets.
- Company: Join a well-established pharmaceutical company dedicated to life-changing products.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth.
- Why this job: Be part of a team that impacts health globally while developing your regulatory expertise.
- Qualifications: Degree in a scientific field and 2+ years in regulatory affairs required.
- Other info: Contact Gareth Gooley for a confidential chat about this exciting opportunity.
The predicted salary is between 36000 - 60000 £ per year.
Are you a Regulatory Affairs professional with a keen eye for compliance and a passion for bringing life-changing products to market? Smart4 Sciences is partnering with a well-established pharmaceutical company who are looking to add a Regulatory Affairs Officer to their growing team.
About the Role:
As the Regulatory Affairs Officer, you'll play a critical part in ensuring regulatory compliance across UK, EU, and international markets. From product registration to post-market vigilance, you'll support the full lifecycle of innovative pharmaceutical and medical device products.
Key Responsibilities:
- Compile and submit regulatory dossiers (new registrations, variations, renewals, CTAs).
- Maintain current knowledge of MHRA, EMA, FDA, UK MDR 2002, and EU MDR 2017/745 requirements.
- Liaise with regulatory bodies to resolve queries and secure timely approvals.
- Manage post-market surveillance, change controls, and regulatory impact assessments.
- Approve labelling and packaging for regulatory compliance.
- Maintain regulatory databases and technical documentation.
What You'll Need:
- Degree in a scientific discipline, chemical engineering or similar (or equivalent experience).
- 2+ years of regulatory affairs experience in pharma or medical devices.
- Strong understanding of GMP, GDP, and ISO 13485.
- Analytical mindset with excellent communication and problem-solving skills.
- Experience influencing stakeholders and working cross-functionally.
Ready to take the next step in your regulatory career? Apply now or contact Gareth Gooley at Smart4 Sciences for a confidential conversation.
Regulatory Affairs Officer - Pharmaceuticals employer: Smart4Sciences
Contact Detail:
Smart4Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer - Pharmaceuticals
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines from MHRA, EMA, and FDA. Being well-versed in these requirements will not only boost your confidence but also demonstrate your commitment to compliance during any discussions.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry conferences or webinars to connect with others who can provide insights into the role and potentially refer you to opportunities within their organisations.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully navigated regulatory challenges in the past. Highlighting your problem-solving skills and ability to influence stakeholders will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest trends and innovations in pharmaceuticals and medical devices. Showing that you are proactive about industry developments can impress potential employers and indicate your passion for the field.
We think you need these skills to ace Regulatory Affairs Officer - Pharmaceuticals
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Affairs Officer. Familiarise yourself with the key requirements mentioned in the job description, such as knowledge of MHRA, EMA, and FDA regulations.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory affairs, particularly in pharmaceuticals or medical devices. Emphasise your understanding of compliance standards like GMP, GDP, and ISO 13485, as well as any specific achievements in previous roles.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your analytical mindset. Mention specific examples of how you've successfully navigated regulatory processes or influenced stakeholders in past positions.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Smart4Sciences
✨Know Your Regulations
Familiarise yourself with the latest regulations from MHRA, EMA, and FDA. Being able to discuss these in detail will show your expertise and commitment to compliance.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed regulatory submissions or resolved compliance issues. This will demonstrate your hands-on experience and problem-solving skills.
✨Communicate Clearly
Practice articulating complex regulatory concepts in simple terms. Strong communication is key in this role, especially when liaising with stakeholders and regulatory bodies.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory processes and challenges they face. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
