Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Technical Drug Regulatory Affairs Manager

Eingestellt von Randstad (Schweiz) AG

Gesuchte Skills: Client, Marketing

Projektbeschreibung

TECHNICAL DRUG REGULATORY AFFAIRS MANAGER

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich, we are excited to help you in your search. We focus on finding the best contracts for the best contractors.

Our client a pharmaceutical company in Basel is looking for a Technical Drug Regulatory Affairs Manager.

Pharma Technical Regulatory (PTR) acts as the center of excellence for all technical regulatory activities for global development and marketed product. The Technical Drug Regulatory Affair Manager in the Biotech Development Group sets and maintains the technical regulatory standards for the Chemistry Manufacturing and Control (CMC) submissions. You will be responsible for developing and executing regulatory strategies for products under development.

KEY RESPONSIBILITIES:

- Represent the technical regulatory function on cross-functional teams with respect to Drug- and Device Combination Product
- Provide strategic leadership and regulatory guidance to the teams/functions on technical regulatory Drug- and Device Combination Product issues
- Successfully negotiate technical regulatory plans
- Manage the generation of high quality global regulatory submissions for clinical trials and marketing authorization applications in collaboration with the other disciplines
- Apart from your proven Regulatory CMC experience with regards to preparation of regulatory applications and submissions, planning of regulatory strategies, assessing regulatory compliance and supporting quality systems, we require knowledge in Biotechnology as well as Drug- and Device combination Product experience

Further to these, we are looking for someone with the following skills: 

- University degree (Master or PhD) in a scientific discipline
- Minimum 3 years of industry experience in regulatory, and Drug- and Device combination Product
- Excellent communication, collaboration, and interpersonal skills
- Effective problem solving and strong organizational skills, including ability to prioritize tasks

If this role excites you, and you feel you could take this next challenge in your career, then don't hesitate to send your application.

Human Forward!

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    1 Year (+)

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Randstad (Schweiz) AG