Global Program Regulatory Manager

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

YOUR EXPERIENCE/SKILLS:

- Excellent knowledge of regulatory submission and approval processes as well as portfolio brand management
- Proficiency in terms of product licenses, especially regarding preparation of documents for EU license renewals
- Expertise in HA negotiations as well as a solid understanding of post-marketing/brand optimization strategies and commercial awareness
- Languages: fluent English both written and spoken

YOUR TASKS:

- Maintaining product licenses world-wide for assigned products as well as preparing IND/NDA Annual Reports and DSURs
- Operationally executing specific regulatory deliverables relating to world-wide maintenance, upkeep and life cycle management of assigned global portfolio brands
- Preparing all necessary supporting documentation for EU license renewals, EU variations and PSUR submissions
- Addressing HA requests and leading preparation of HA responses
- Managing interactions with RA colleagues in CPOs and participating in regulatory subteams; preparation of IND/NDA Annual Reports & DSURs

START: ASAP
DURATION: 6MM+
LOCATION: Basel, Switzerland
REF.NR.: BH12934

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.

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In case of successful placement, we support you with:

- All administrative questions
- Finding an apartment
- Health - and social insurance

Work permit and much more