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Regulatory Affairs Specialist
- belfast, northern ireland, BT2 8JU, United Kingdom
- Permanent·Hybrid
- Full time
- £50,000 - £50,000 Per Annum
Job Description
About the Role
Our client is seeking a detail-oriented Regulatory Affairs Specialist to join their dynamic team in Belfast . This role is crucial for ensuring that the company's pharmaceutical products meet all relevant regulatory requirements for market approval and compliance across various territories. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This is an excellent opportunity to contribute to patient safety and access to medicines within a progressive pharmaceutical company .
Key Responsibilities
- Prepare, review, and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals to national and international health authorities.
- Interpret and apply regulatory guidelines (e.g., FDA, EMA, MHRA) to product development, manufacturing, and marketing activities.
- Act as a key liaison between the company and regulatory agencies, responding to queries and facilitating communication.
- Monitor changes in the regulatory environment and assess their impact on company products and strategies.
- Ensure that all promotional materials and labeling comply with regulatory requirements and company policies.
Requirements
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Demonstrated experience in preparing and submitting regulatory documentation for various markets.
- Strong understanding of global regulatory submission processes and requirements.
- Excellent written and verbal communication skills, with strong analytical and problem-solving abilities.
Benefits
- Competitive salary package with annual review.
- Comprehensive health and wellness benefits.
- Pension contributions and life insurance.
- Professional development budget for conferences and training.
- Hybrid working model offering flexibility in Belfast .