Regulatory Affairs Specialist
4 weeks ago
We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Fusion Pharma Limited. As a key member of our Regulatory Affairs Department, you will play a crucial role in ensuring the compliance of our clients' products with regulatory requirements in the UK and EU.
Key Responsibilities:- Develop and implement regulatory strategies for our clients' products, including Life Cycle Management activities
- Author and compile regulatory documents, such as CMC and safety variations, Art 61(3), PSURs, and MAAs
- Collaborate with our clients' teams to support their regulatory needs, including representation during internal/external audits or Health Authority inspections
- Contribute to the development of regulatory intelligence, including interpreting changes and communicating these to our community
- Participate in business development activities, such as creating marketing materials and representing Fusion Pharma at conferences and networking events
- Life Sciences degree
- Fluent in written and spoken English with excellent communication skills and attention to detail
- Minimum of 3 to 5 years Reg Affairs experience, aligned with our essential experience
- Proficient in Microsoft Office applications and ability to learn new electronic systems
- Proven competency in working autonomously and multi-tasking in a fast-paced environment
- Commitment to representing Fusion Pharma to a high standard, face-to-face and remotely
- Competitive salary
- Permanent and full-time position
- Flexible working hours
- Remote working
- 6 weeks holiday
- Private healthcare
- Pension
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