Our Mission:
Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.
We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.
The Role:
We are looking for a Senior Regulatory Affairs Associate to join our Regulatory Affairs & Technical Writing team where you will be responsible for the coordination of Global Clinical Trial applications of new and established medical products and devices, ensuring that applications are conducted in accordance with the latest ICH and Regulatory guidelines. You will ensure that submission documentation is submitted in a timely manner and that the client, operational team and Regulatory Senior Management are kept fully informed of all aspects of the project.
Key Accountabilities:
- Act as the Regulatory Lead for designated complex global and early phase clinical trials.
- Prepare, review and submit clinical trial applications to Regulatory Authorities, Ethics Committees and any other required regulatory authority.
- Assist in producing investigator brochures, protocols, IMPDs and other supporting regulatory documentation.
- Prepare Patient Information and Consent Documents and other patient facing documentation.
- Support Regulatory Affairs department in maintaining awareness and compliance of current local, national, regional and harmonised guidance and requirements for the format, content, and control of all types of regulatory and ethics procedures and submissions.
- Assist Project Managers with month end financial reporting on their projects.
- Supervise and mentor less experienced Regulatory Affairs team members.
- Perform other duties as assigned by Regulatory Affairs & Technical Writing management team such as developing and writing SOP’s, assisting in Business Development activities etc.
Skills Required:
ESSENTIAL
- Bachelor's degree within Science or medical field or equivalent
- Extensive experience in submitting clinical trial applications globally to the relevant Regulatory Authorities and Ethics Committees.
- Extensive experience and understanding of ICH-GCP.
- In depth experience with the EU Directive and National Requirements for clinical trials.
- Experience in project reporting and liaising with multiple stakeholders, including clients and internal operational teams.
- Excellent command of the English language (written and oral) as well as local language where applicable
- Excellent analytical, planning, investigative and problem-solving skills
DESIRABLE
- Advanced degree (Masters, PhD) or equivalent
- Experience in Clinical Trial submission management of international clinical studies
- Extensive experience of working with regulatory agencies.
- Understanding of pharmaceutical/drug manufacturing in terms of development, manufacturing and quality.
- Fluent in another European language
About Us:
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.
