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Pharmaceutical Regulatory Affairs Specialist
- belfast, northern ireland, BT1, United Kingdom
- Permanent·Hybrid
- Full time
- £58,000 - £58,000 Per Annum
Job Description
About the Role
Our client is seeking a diligent and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their dedicated team in Belfast . This role is crucial for ensuring that all of the company's pharmaceutical products comply with national and international regulatory requirements, facilitating timely approvals and market access. You will be responsible for preparing and submitting regulatory dossiers, managing post-approval changes, and staying abreast of evolving regulatory landscapes. This position offers an excellent opportunity for a regulatory professional to contribute to a leading pharmaceutical company, working within a structured framework that prioritizes compliance and product stewardship.
Key Responsibilities
- Prepare, review, and submit regulatory submissions (e.g., CTAs, MAAs, NDAs) to health authorities in various global markets.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other applicable regulations.
- Manage post-approval regulatory activities, including annual reports, supplements, and variations.
- Liaise with internal departments (R&D, Manufacturing, Quality Assurance) and external regulatory agencies to resolve regulatory issues.
- Monitor and interpret new and existing pharmaceutical regulations and guidelines, advising the business on their impact.
Requirements
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry .
- Strong knowledge of global regulatory submission requirements and processes.
- Experience with regulatory submission software and databases.
- Excellent written and verbal communication skills, with a keen eye for detail and strong analytical capabilities in Belfast .
Benefits
- Competitive salary commensurate with experience.
- Comprehensive health insurance and wellness programs.
- Pension contributions and life assurance coverage.
- Generous annual leave entitlement.
- Hybrid work model offering flexibility between office and home working.