Drug Regulatory Affairs Clinical Trial Manager

vor 1 Woche

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**_T_**_he Life Science Career Network_**

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a:
**Drug Regulatory Affairs Clinical Trial Manager 100% - 5716 LBD**

10-month contract based in Basel area with possibility for extension.

**Main Responsibilities**:
**Tasks related to Clinical Trial Applications (CTAs)**:

- Interact with internal departments or teams and third parties (e.g. External Service Providers [ESPs]) as
- required to give regulatory input and guidance for clinical trials and their submission to European and
- international Health Authorities (HAs).
- Prepare, submit and maintain CTAs to European and international HAs in accordance with the applicable regulatory requirements.
- Liaise with internal, regional and/or ESP personnel to request and collect appropriate documents and, where applicable, to arrange submission.
- Interact with HAs and/or other parties regarding CTAs.
- Ensure proper running of the trial during its life cycle from a regulatory perspective.
- Ensure that timelines are met for submissions such as answers to HA questions, End of Trial notifications, Clinical Study Report synopsis, etc.
- Maintain tracking sheets listing submission and approval dates per country for initial CTA, amendments,
- End of Trial notifications and submission of Clinical Study Report synopsis.

**Tasks related to the Clinical Trial Team (CTT)**:

- Attend and contribute to CTT meetings, providing regulatory updates and information as required.
- Discuss country timelines and prioritize submissions in conjunction with relevant CTT members.
- Provide advice to CTT members on HA CTA submission processes and other related submissions, such as amendments, End of Trial notifications, etc.
- Keep the relevant CTT members informed of the status of HA-related matters, including providing relevant documentation in a timely manner

**Requirements**:

- **Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;**:

- Previous experience in preparing, submitting and maintaining Clinical Trial Applications to European and International Health Authorities in accordance with the applicable regulatory requirements
- Thorough understanding of the regulatory requirements applicable for submission and maintenance of CTAs in and outside of Europe (e.g., Clinical Trial Directive, Clinical Trials Regulation, etc.)
- Excellent organizational, interpersonal, and communications skills, together with meticulous attention to detail
- Ability to work efficiently and effectively to tight deadlines
- Excellent spoken and written English (knowledge of another European language would be an advantage

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