Regulatory Affairs Specialist
- edinburgh, scotland, G2 8YR, United Kingdom
- Permanent·Hybrid
- Full time
- £59,000 - £59,000 Per Annum
Job Description
About the Role
Our client is looking for a diligent and knowledgeable Regulatory Affairs Specialist to join their dynamic team in Glasgow . In this role, you will be instrumental in ensuring that our client's pharmaceutical products meet all national and international regulatory requirements for marketing authorization and compliance. You will prepare and submit regulatory dossiers, liaise with health authorities, and provide strategic guidance on regulatory pathways. This position is crucial for facilitating the timely launch and continued market access of innovative therapies. You will work within a collaborative environment, contributing to the success of a company dedicated to improving global health, operating from their base in Glasgow , Scotland.
Key Responsibilities
- Prepare, compile, and submit regulatory documentation for new product registrations and variations in various global markets.
- Interpret and apply relevant regulatory guidelines and legislation to product development and lifecycle management.
- Liaise effectively with regulatory authorities, responding to queries and facilitating the approval process.
- Review and approve promotional materials and product labelling to ensure regulatory compliance.
- Provide regulatory intelligence and strategic advice to project teams and senior management.
Requirements
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 4 years of experience in pharmaceutical regulatory affairs.
- Proficiency in preparing Common Technical Document (CTD) dossiers and knowledge of global regulatory submission requirements.
- Excellent understanding of pharmaceutical regulations and guidelines across key markets.
- Strong written and verbal communication skills, with a keen eye for detail.
Benefits
- Competitive salary and performance-based incentives.
- Comprehensive healthcare coverage and wellness benefits.
- Generous holiday allowance and company pension scheme.
- Opportunities for professional development and international travel for conferences.
- A hybrid work model offering a balance between office-based collaboration and remote flexibility.