The primary responsibilities of the ideal candidate to join the company include:
1. Management, preparation, assembly and submission of European:
➢ Clinical Trial Authorisation Applications (CTAA) and amendments.
➢ Country-level Informed Consent and other patient facing documentation.
2. Tracks, reports and files CTAA and amendment submission/approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems.
3. Provides consultancy to the client on European CT regulatory specific issues.
4. Participates in the quality control (QC) steps involved for all of the above.
5. Serves as key regulatory liaison for multi-continental projects on behalf of the company (Europe). Liaison with other departments within the company, including Data Management, Medical Writing, Pharmacovigilance, Quality Assurance and Drug Distribution.
6. Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by regulatory agencies.
7. Provides regulatory training to other members of the team as required.
Life-sciences graduate with at least 12 months of industry experience in a regulatory environment (minimum entry level).
Prior working experience with CT ethics committee and regulatory authority submissions in 2 or more countries (Senior levels).
Knowledge of ICH-GCP and local regulatory agency and Ethics Committee regulations and requirements (Detailed knowledge for senior levels).
The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities.
Excellent interpersonal skills Strong communication skills: verbal/written
Fluency in written and spoken English
Proven ability to demonstrate problem solving skills
Proven ability to meet deadlines Highly organized and result-oriented
Good knowledge of Windows-based software programs