Regulatory Affairs Specialist
4 days ago
Discover a world of difference at Lifelancer
Job Title: Regulatory Affairs Specialist - European Compliance ExpertThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist, where you will play a pivotal role in navigating the complex regulatory landscape and ensuring the success of diverse clinical trials.
The Regulatory Affairs Department at Worldwide Clinical Trials is instrumental in leading submissions to regulatory authorities, coordinating with ethics committees across EMEA, Asia Pacific, and Latin America, and ensuring compliance with evolving regulations.
As a subject matter expert, you will be responsible for planning, initiating, and tracking documents required for regulatory submissions, essential documents collection, review, and provision of country/site/EC requirements to support the achievement of site activation goals and communicating status, risks and actions related to any start-up activities and maintenance when applicable.
Key Responsibilities:
- Subject Matter Expert (SME) for Regulatory Submissions
- Planning, Initiating, and Tracking Documents Required for Regulatory Submissions
- Collection, Review, and Provision of Country/Site/EC Requirements
- Communicating Status, Risks, and Actions Related to Start-up Activities and Maintenance
Requirements:
- Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum two years of experience in clinical research, in site activation and/or regulatory-related function within a CRO
- Candidates must have experience of the regulatory process under EU-CTR in Austria and/or Germany to be considered for this role
- Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
About the Company:
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
Educational Qualifications:
- Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
Experience:
- Minimum two years of experience in clinical research, in site activation and/or regulatory-related function within a CRO
- Candidates must have experience of the regulatory process under EU-CTR in Austria and/or Germany to be considered for this role
Preferred Skills:
- Strong organizational and management skills
- Self-motivated learning about current regulatory processes and intelligence
- Proactive by identifying potential issues in the process and anticipating solutions
- Thorough understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
Salary: £45,000 - £60,000 per annum
Location: London, UK (Remote)
Job Type: Full-time
Benefits:
- Paid annual leave
- Health insurance
- Training and development opportunities
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