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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.
Regulatory Affairs Officer – Pharmaceuticals & Medical Devices – Hull
Are you a Regulatory Affairs professional with a keen eye for compliance and a passion for bringing life-changing products to market? Smart4 Sciences 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:
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Compile and submit regulatory dossiers (new registrations, variations, renewals, CTAs).
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Maintain current knowledge of MHRA, EMA, FDA, UK MDR 2002, and EU MDR 2017/745 requirements.
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Liaise with regulatory bodies to resolve queries and secure timely approvals.
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Manage post-market surveillance, change controls, and regulatory impact assessments.
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Approve labelling and packaging for regulatory compliance.
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Maintain regulatory databases and technical documentation.
What You\’ll Need:
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Degree in a scientific discipline, chemical engineering or similar (or equivalent experience).
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2+ years of regulatory affairs experience in pharma or medical devices.
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Strong understanding of GMP, GDP, and ISO 13485.
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Analytical mindset with excellent communication and problem-solving skills.
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Experience influencing stakeholders and working cross-functionally.
Ready to take the next step in your regulatory career?
Apply now or contact Gareth Gooley on at Smart4 Sciences for a confidential conversation.
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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 with potential employers.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry conferences or webinars where you can meet people who work in similar roles. This can lead to valuable connections and insights that may help you stand out when applying for the position.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed regulatory submissions or resolved compliance issues in your previous roles. Having concrete examples ready will showcase your experience and problem-solving skills effectively during interviews.
✨Tip Number 4
Stay updated on industry trends and emerging technologies in pharmaceuticals and medical devices. Showing that you are proactive about learning and adapting to changes in the field can set you apart as a candidate who is ready to contribute to the company's success.
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.
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 in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no spelling or grammatical errors, as attention to detail 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. Be prepared to discuss how these regulations impact the role and your previous experiences in ensuring compliance.
✨Showcase Your Experience
Highlight your 2+ years of experience in regulatory affairs, particularly in pharmaceuticals or medical devices. Use specific examples of how you've compiled regulatory dossiers or managed post-market surveillance.
✨Demonstrate Analytical Skills
Prepare to discuss scenarios where your analytical mindset helped solve complex problems. Think of examples where you influenced stakeholders or worked cross-functionally to achieve regulatory goals.
✨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 the company is the right fit for you.
