Regulatory Affairs Manager (m/f/d)
Your responsibilities
- Follow-up sending, submission and approval of CTA package with affiliate (GRA affiliates, or partners, as appropriate)
- Contribute to preparation of HA meeting, if any (e.g. consultation of HA for discussion on a protocol)
- Manages CTAs activities related SOPs (ie. Coordinates the creation, updates of the QDs)
- Identify any issues and propose resolution
- Provide support to Development Safety Update Report (DSUR) distribution preparation and assure the appropriate tracking of submissions for all entities
- Contribute to set up of new processes for new regulations implementation (e.g. New EU Clinical Trial Regulation, EU Clinical Data Disclosure)
- Build expertise in databases use (e.g. VEEVA Registrations Tracking), use communication tools (e.g. sharepoint I-connect to communicate within Corporate and affiliates)
- Coordinate all user activities regarding the tracking of regulatory events in relation with clinical trials & all global and local disclosure activities
- Act as GRA window person for interactions with the Solution Leader, Solution Specialists, the other Expert Users. o Quality Control (QC) VEEVA RT information content: Improve data quality
- Establish and maintain effective interfaces & communication with the VEEVA-RT user community/any other internal function to support achievement of GRA productivity goals
- Metrics: Provide the VEEVA-RT user community with meaningful metrics on various VEEVA-RT related topics
Your profile
- Physician, Pharmacist or Life Sciences Degree Comprehensive knowledge and operational expertise in clinical trials regulation
- Work experience in the pharmaceutical industry, in international regulatory affairs or in clinical development
- Problem-Solving skills, critical thinking
- Understanding the factors that adversely impact the preparation of CTAs, worldwide and propose mitigation solutions accordingly
- Responsible for the success of the CTAs preparation, submission and life cycle management, and operational aspects of ongoing clinical trials to ensure meeting all required timelines as well as adherence of quality and performance expectations. Ability to work with multifunctional and multicultural teams
- Take responsibility for decisions and accept accountability for results. Set a clear and persuasive direction, while communicating timelines and project goals with clarity. Act in a proactive, positive, and responsive manner to customer needs. Build good working strong relationships and act as a role model and change agent for the CTA coordination team. Form strong stakeholder management
- Risk Management: Ability to anticipate and mitigate risks/issues related to the CTA E2E process. Connect and anticipate the evolution of the internal and external environment and adapt processes as appropriate.
- Strong command of the English language, both spoken and written
Your benefits
- Support throughout the application process
- Assistance during the project by our team at Hays
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in 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 experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
+49 30 847884 166© Copyright Hays plc, . Das Wort HAYS, die H-Symbole, „Hays Working for your tomorrow" und „Powering the world of work" sowie damit verbundene Logos und Illustrationen sind eingetragene Markenzeichen der Hays PLC. Die H-Symbole sind Originaldesigns, die in vielen Ländern geschützt sind. Alle Rechte vorbehalten.