QA and Regulatory Consultant (m/f/d)

REFERENCE NUMBER:

475104/1

MY DUTIES:

- Strategic and tactical input in development, post-approval and Life cycle management
- Liaison with Regulatory Agencies and Local Operating Companies
- Input in document and process development
- Clinical Trial Applications (CTA) 
- Marketing Authorization Application (MAA)
- Resource Planning and Management

MY QUALIFICATIONS:

- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
- Experience with EU regulatory procedures (CP, MRP, national)
- Experience in working in project teams and/or a matrix organization
- Negotiating and conflict handling skills
- People management skills
- Complex project management skills
- Oral and written communication skills
- Organization and multi-tasking skills  
- Excellent knowledge of English
- Knowledge of the applicable therapeutic area
- In-depth knowledge of the regulatory environment, guidelines and practice of EMEA regions

MY BENEFITS:

- A very renowned company
- A city with a high quality of life that perfectly embraces both modern and traditional values
- Continuous support during the assignment
- High degree of personal responsibility

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-Sebastian Heftrich

Reference number
475104/1

Contact
E-Mail: [email protected]