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Global Maintenance Regulatory Manager

Eingestellt von RM IT Professional Resources AG

Gesuchte Skills: Support, Client

Projektbeschreibung

Global Maintenance Regulatory Manager wanted for our Basel based client in the pharmaceutical sector.

YOUR EXPERIENCE/SKILLS:

- University Degree, preferred PhD in the following sections like Life Sciences, Pharmacy or Medicine
- 2+ years' work experience in related areas of the pharma Industry or Health Authorities
- 5+ profound experience within EU as well as global regulatory affairs
- Demonstrated ability to collaborate across partner functions in a Matrix environment together with good performance of communication skills
- Solid understanding of all aspects of clinical drug development
- Languages: fluent English both written and spoken, additional European Languages are advantageous

YOUR TASKS:

- Coordinating the preparation of all documents needed for EU license renewals
- Cooperating with the EU and other Rest of World Health Authorities to find solutions of issues related to assigned registered products
- Leading the HA Response Team through the regulatory maintenance processes as well as representing RA in negotiations with HA in EU
- Managing the collaboration with RA colleagues in CPOs and agents of the company for activities related to regulatory management
- Achieving harmonization across EU by supporting EU referral procedures
- Providing responses to regulatory concerns from various stakeholders as HAs, CPOs relating to selected brands as well as collaborating with relevant GLFs, in planning and execution of agreed actions which are related to efficient management of regulatory procedures across EU
- Granting DRA input for in- and out-licensing initiatives for selected Established Medicines around the world

START: ASAP
DURATION: 6MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13641

Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.

DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.

GOING THE EXTRA MILE

NEW TO SWITZERLAND? In case of successful placement, we support you with:

- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    8 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

RM IT Professional Resources AG