Regulatory Affairs Officer - Pharmaceuticals & Medical Devices - HullAre you a Regulatory Affairs professional with a keen... Read more
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.
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 on at Smart4 Sciences for a confidential conversation.
QA Officer - Pharmaceutical Manufacturing - HULLJoin a Growing Pharmaceutical Company with a Passion for Quality and Innovation!We... Read more
QA Officer - Pharmaceutical Manufacturing - HULL
Join a Growing Pharmaceutical Company with a Passion for Quality and Innovation!
We are partnering with an ambitious and rapidly expanding pharmaceutical manufacturing company based in Hull to recruit a QA Officer. This is an exciting opportunity to be part of a company making significant investments in their facilities, people, and future.
As a QA Officer, you'll play a vital role in ensuring that quality standards are upheld across all stages of manufacturing and supply. Whether you're an experienced QA Associate looking to take the next step, or already operating as a QA Officer, this role offers the chance to grow in a supportive and collaborative environment.
Key Responsibilities:Support the implementation and maintenance of the Quality Management System (QMS) in line with GMP and regulatory requirements.
Conduct batch record review and assist in product release activities.
Handle deviations, CAPAs, change controls, and customer complaints.
Assist with internal audits and regulatory inspections.
Support document control processes and SOP management.
Collaborate with manufacturing, QC, and supply chain teams to promote a culture of continuous improvement.
Ideal Candidate Profile:Prior experience in a GMP-compliant pharmaceutical environment, ideally within a CDMO.
Strong understanding of pharmaceutical quality systems and regulatory guidelines.
Excellent attention to detail and communication skills.
Ability to work both independently and as part of a team.
Science degree or relevant qualification preferred.
Why Join?Be part of a growing business with exciting expansion plans.
Modern facilities and a forward-thinking team.
Genuine opportunities for progression and development.
Competitive salary and benefits package.
Positive, quality-driven culture.
Ready to take your QA career to the next level in a company that's going places?
Apply now or contact Gareth Gooley on for more info
Validation Engineer - Pharmaceuticals - Hull Salary negotiable Are you looking for your next step in Pharmaceutical Validation... Read more
Validation Engineer - Pharmaceuticals - Hull
Salary negotiable
Are you looking for your next step in Pharmaceutical Validation ?
This company is experiencing an exciting period of growth, known for internal progression & variation, this is great place to progress your skills & expertise in Validation Engineering.
As the Validation Engineer, you will benefit from working on various projects including exposure to the full validation life from Design Qualification through to operational handover & inclusive of CSV.
Desirable Experience & Qualifications
Broad validation experience in GMP Experience in cGMP Annex 11, 21 CFR Part 11, GAMP 5. Able to write URS and VMP (DQ, OQ, IQ, PQ)would like to discuss please get in touch & apply now or contact Simon Fowler at NGAGE Smart4Sciences
Read lessfor the following search criteria
