CTA Specialist (m/f/d)

REFERENCE NUMBER:

601207/1

MY DUTIES:

- Prepare, compile and submit country-specific CTA dossiers in selected countries And organize the timely and effective generation of CTA documents to ensure CTA submission is performed on time and with high quality documents
- Prepare core CTA dossier and/or control the quality of the core CTA dossier
- Ensure accurate and timely tracking and archiving of CTA activities
- Maintain and improve processes, procedures and systems which support the global management of CTAs
- Participate in or co-chair the CTA regulatory meetings as per the standard operating procedure
- Under the supervision of the GRSL, management and oversight of First Service Provider (FSP) and Contract Research Organizations (CROs) performing CTAs to ensure quality, timely approvals, and compliance. Ensuring synergies/lessons learned are used to improve CTA approval processes and timelines
- Keep abreast of new CTA requirements, regulations and guidance documents
- Maintain a CTA knowledge database with up to date information on ongoing and past clinical trials (e.g. countries benchmarking, list of questions, submission requirements, etc.)

MY QUALIFICATIONS:

- A minimum of 3+ years’ experience in Regulatory Affairs or Clinical Research, preferably with experience in managing Clinical Trial Authorizations
- Knowledge of regulatory requirements in key markets for obtaining Clinical Trial Authorizations
- Knowledge of ICH guidelines/GCP and current medical/scientific/regulatory knowledge
- Excellent written and oral communication skills in English – German is a plus

MY BENEFITS:

- A very renowned company

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Marc Peter Linder

Reference number
601207/1

Contact
E-Mail: [email protected]