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Pharmaceutical Regulatory Affairs Specialist
- belfast, northern ireland, BT1 5JD, United Kingdom
- Permanent·Remote
- Full time
- £60,000 - £60,000 Per Annum
Job Description
About the Role
Our client is seeking a diligent Pharmaceutical Regulatory Affairs Specialist to contribute to their compliance efforts from Belfast . This role is essential for ensuring that our pharmaceutical products meet all national and international regulatory standards for marketing authorization and lifecycle management. You will work closely with various internal departments, including R&D, manufacturing, and legal, to prepare and submit regulatory dossiers. This is a fantastic opportunity for a meticulous professional to play a key role in bringing life-saving medications to patients globally, operating in a fully remote capacity.
Key Responsibilities
- Prepare, review, and submit regulatory submissions (e.g., MAAs, NDAs) to health authorities worldwide.
- Maintain regulatory compliance for existing product portfolio, including post-approval changes.
- Interpret and communicate regulatory requirements and guidelines to internal stakeholders.
- Liaise with regulatory agencies during the review process and respond to queries.
- Monitor the regulatory landscape for changes affecting pharmaceutical products.
Requirements
- Degree in Pharmacy, Chemistry, Biology, or a related discipline.
- Minimum of 4 years of experience in pharmaceutical regulatory affairs.
- Comprehensive knowledge of global regulatory requirements for drug registration.
- Experience with regulatory submission software and databases.
- Excellent written and verbal communication skills, essential for remote collaboration in Belfast .
Benefits
- Competitive salary with regular performance reviews.
- Remote work flexibility, enhancing work-life balance.
- Comprehensive private medical and dental coverage.
- Generous allowance for professional training and development.
- Opportunity to shape regulatory strategy for innovative pharmaceutical products.