Are you interested in an exciting career opportunity for a Regulatory Affairs Associate II with expertise in Clinical Trial Applications (CTAs) in the United Kingdom (UK)? Are you also a highly skilled professional seeking a challenging role in regulatory affairs within the clinical research field, this position might be perfect for you.
Job Description:
Your responsibilities will include:
- CTA compilation and submission: You will be responsible for compiling and submitting CTAs, ensuring accuracy and completeness of documentation, and coordinating with regulatory authorities to obtain approvals for clinical trials.
- Regulatory compliance: You will ensure adherence to relevant regulations, guidelines, and International Council for Harmonisation (ICH) standards throughout the clinical trial lifecycle. This includes maintaining compliance with Good Clinical Practice (GCP) guidelines and other applicable regulatory requirements.
- Regulatory strategy and support: You will contribute to the development of regulatory strategies and provide expertise and guidance on regulatory matters to cross-functional teams. This may involve evaluating new regulations, assessing their impact on ongoing trials, and proposing necessary adjustments.
- Collaboration and communication: You will collaborate closely with internal stakeholders, including clinical teams, investigators, and partners, to facilitate efficient regulatory processes and address any regulatory challenges that arise.
Qualifications and Skills:
To succeed in this role, you should possess the following qualifications and skills:
- Educational background: A bachelor’s or master’s degree in a relevant scientific discipline or regulatory affairs is preferred.
- Regulatory experience: A minimum of 1-2 years of experience in regulatory affairs, with a focus on CTAs and clinical trials in the UK, is required. Experience working with regulatory authorities, such as the Medicines and Healthcare Products Regulatory Agency (MHRA), is highly desirable.
- In-depth knowledge: Strong understanding of UK regulatory requirements for clinical trials, including experience with CTAs and familiarity with ICH guidelines and GCP standards, is essential.
- Attention to detail: Exceptional attention to detail, organizational skills, and the ability to manage multiple projects concurrently are crucial for success in this role.
- Communication and teamwork: Excellent written and verbal communication skills are necessary for effective collaboration with internal and external stakeholders. The ability to work well within cross-functional teams is also important.
How to Apply:
If you are ready to take on this exciting opportunity and contribute to the advancement of regulatory affairs in clinical trials, please click apply below to start your journey to a successful career.
This is a remarkable chance to join a great team as a Regulatory Affairs Associate II CTA in the UK and make a significant impact on the successful execution of clinical trials. By leveraging your regulatory expertise and knowledge of CTAs, you will play a crucial role in ensuring compliance, patient safety, and the advancement of medical research. Don’t miss out on this rewarding career opportunity—apply today