Open roleExternal
Regulatory Affairs Specialist
- bradford, west yorkshire, BD1 1SX, United Kingdom
- Full time
- Hybrid
- £55,000 - £55,000 Per Annum
Job Description
About the Role
Our client is seeking a knowledgeable and proactive Regulatory Affairs Specialist to join their regulatory compliance team in Bradford . This role is essential for ensuring that all company products meet the stringent requirements of global health authorities. You will be responsible for preparing and submitting regulatory documentation, liaising with regulatory agencies, and providing expert guidance on regulatory strategies to support product development and lifecycle management. This is a fantastic opportunity for an individual keen to navigate the complex regulatory landscape of the pharmaceutical industry and contribute to market access for innovative medicines.
Key Responsibilities
- Prepare, review, and submit regulatory submissions (e.g., MAA, NDA, variations) to global health authorities.
- Monitor and interpret evolving regulatory guidelines and advise internal teams on compliance requirements.
- Liaise with regulatory agencies on behalf of the company for product registration and post-approval changes.
- Develop and maintain regulatory documentation, databases, and filing systems.
- Provide regulatory support for product development, marketing, and lifecycle management activities.
- Collaborate with R&D, manufacturing, and commercial teams to ensure regulatory strategies align with business objectives.
Requirements
- Bachelor's degree in a life science, pharmacy, or related field; advanced degree preferred.
- Proven experience in regulatory affairs within the pharmaceutical or medical device industry.
- Strong understanding of international regulatory requirements (e.g., EMA, FDA) and ICH guidelines .
- Experience in preparing and submitting various types of regulatory dossiers.
- Excellent analytical, organizational, and communication skills.
- Ability to work independently and manage multiple projects simultaneously.
Benefits
- Competitive salary and attractive benefits package.
- Flexible hybrid working arrangements to support work-life balance.
- Opportunities for professional development and continued learning in regulatory affairs.
- Exposure to diverse regulatory challenges and international markets.
- Join a dedicated team focused on ensuring patient access to safe and effective medicines in Bradford .