Beschreibung
On behalf of our client in the Life Science industry, Harvey Nash is looking for a DRA Global Program Regulatory Manager for a 12 month project in Switzerland.
The role
- Responsible for implementing regulatory strategy and managing operational activities
- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan and Seed Document
- Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and KOLs
- Determines requirements and sets objectives for HA interactions with DRA
- Interact with HA - plan, organise and coordinate HA meetings and develop and implement plans
- Responsible for integrating global strategy into regional submissions worldwide
- May serve as local HA liaison depending on location (FDA/EMA)
- Responsible for submission of CTAs and INDs
- Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the DRA GPT representative and/or GTAL
Requirements
- 2-4 years experience in regulatory affairs within Pharma/Biotech company
- Knowledge in submissions and approval for drug regulatory
- Experience in HA negotiations
- Experience with phase I-IV clinical trials, including regulatory strategy and understanding of post marketing strategies
- BSc/MSc in scientific related field or equivalent
- Fluent English required additional languages are an asset
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred). For further details feel free to call me. Im looking forward to receiving your application.