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Senior Regulatory Affairs Specialist - Pharmaceuticals
- glasgow, scotland, EH1 1EN, United Kingdom
- Permanent·Hybrid
- Full time
- £70,000 - £70,000 Per Annum
Job Description
About the Role
Our client is seeking a strategic and experienced Senior Regulatory Affairs Specialist to join their dynamic team in Edinburgh . This role is crucial for navigating the complex global regulatory landscape, ensuring that the company's pharmaceutical products meet all necessary approvals and compliance standards worldwide. You will be responsible for developing and executing regulatory strategies, preparing submission dossiers, and engaging with health authorities. This hybrid position offers the chance to work on groundbreaking therapies while enjoying a flexible work arrangement, contributing to a company culture that values scientific innovation and patient well-being in the global pharmaceutical market .
Key Responsibilities
- Develop and implement global regulatory strategies for new pharmaceutical products and lifecycle management.
- Prepare and submit regulatory dossiers (e.g., CTAs, MAAs, NDAs) to health authorities in key markets, ensuring compliance with regional requirements.
- Liaise with regulatory agencies, respond to queries, and manage the regulatory submission process from start to finish.
- Monitor changes in the regulatory environment and assess their impact on company products and strategies in Scotland .
- Provide regulatory guidance and support to internal R&D, clinical, and commercial teams, ensuring alignment with regulatory objectives within the pharmaceutical sector .
Requirements
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
- Significant experience (5+ years) in regulatory affairs within the pharmaceutical industry , with a strong understanding of global regulatory requirements.
- Proven experience in preparing and submitting regulatory dossiers for various product types and regions.
- Excellent understanding of drug development processes and CMC requirements.
- Exceptional communication, negotiation, and problem-solving skills, with the ability to manage multiple projects concurrently from our Edinburgh base.
Benefits
- Competitive salary and performance-based bonus.
- Comprehensive health, dental, and vision insurance.
- Generous annual leave and company pension.
- Hybrid work model promoting flexibility and work-life balance.
- Support for professional development and industry certifications.