CTA(Clinical Trials Application) Regulatory Manager

Our Team:

The Clinical Trial Application Regulatory Manager (CTA-RM) is the responsible person to ensure that the regulatory dossiers related to Clinical studies( New initial CTA, Amendments, Notification, DSUR) are submitted to Regulatory or Health Authorities within set timelines for approval.

• Provides appropriate input and support for the regulatory activities and provides updated information regarding the regulatory environment and trends related to CTA.

• Is the local reference person for regulatory matters concerning clinical trials for internal and external interfaces.

• Ensures liaison with Corporate (Global Regulatory CTA team, GRT and Clinical teams) as needed for all CTA activities especially handling of questions from Health Authority

• Employee of this position will report to the RA manager.

Main responsibilities:

Clinical Trial Application (Initial and subsequent amendment) Regulatory Submission & approval

• Prepare the regulatory package according to the local requirements.

• Coordinate preparing responses to the inquiries raised by Health authorities with relevant global/local stakeholders

• Distribution of CTA packages to the relevant functions and tracking/recording corresponding schedule, communications with HA on the system in a timely manner with completeness and accuracy (e.g., Veeva Vault)  

• Subsequent Notification to HA in accordance with regulatory requirement (e.g., FPI, updated information etc.)

• Communication of country regulatory requirement with global team including clinical trial planning stage but not limited to

• As per need and upon delegation of the country head/lead be Sanofi´s representative in pharma chambers / associations and ensure representation of company in HA working groups / public consultations.

Experience :

At least 2+ years of professional experience in regulatory affairs including CTA activities

Language:

• Good command of English (written and spoken)

Education:

• University Degree or Equivalent preferably in a pharmacy/medical/science-related field

Soft skills:

• Be able to communicate efficiently on different levels, be assertive and can work on several projects at once with high flexibility, be detail oriented and have excellent time management and organizational skills

• Strong networking abilities, problem-solving skills and an ability/willingness to work with internal and external stakeholders across the globe

• Self-motivation with the ability to work under pressure to meet deadlines, works well independently as well as in a team environment

Techinical skills:

• A strong working knowledge of the ICH guidelines and local regulations especially in CTA.

• Knowledge of local regulations is a must