Senior Regulatory Manager (m/f/d), 100%
Einsatzort:Basel
Art(en) der Anstellung:Temporärstelle, Vollzeit
#GPRM #ClinicalTrials #Regulatory #Basel
Please note: For this position we can only consider candidates from Switzerland, candidates with a valid work permit for Switzerland or from an EU/EFTA country.
Our customer, a pharmaceutical company based in the area of Basel, needs reinforcement. For a temporary employment (duration: 5 months, with the option of a possible extension) we are looking for a
The Senior Regulatory Manager works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s).
- Provides input to global program regulatory strategy, including regulatory designations & innovative approaches
- May provide global RA leadership for specific part of the program e.g. new indication, new formulation or act as RA program lead for program of limited complexity
- Coordinates regulatory readiness with other line functions, Country Organizations & Regions
- Represents RA or leads in regional RA or crossfunctional activities
- Provides strategic input to cross functional deliverables (e.g. protocols, IB, safety reports etc)
- Contributes to the development and maintenance of the Core Data Sheet (CDS)
- Determines requirements and coordinates activities for Health Authority (HA) interactions. May lead HAs meetings together with RA program lead.
- May serve as local HA liaison (e.g., FDA or EMA). Regulatory Submissions
- Leads planning, preparation and submission of clinical trials.
- Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
- Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred
- Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data
- Awareness of post-marketing/brand optimization strategies and commercial aspects.
- =4 years involvement in regulatory and pharmaceutical development spanning activi-ties in Phases I-IV in 1 or more major region.
- Experience in leading cross-functional teams
- Fluency in English both written and spoken is requirement as a business language. Additional language is an asset.
- Good working atmosphere and modern office facilities
- Further training opportunities
renato_imboden
Abteilungen:Life Sciences
Arbeitsort
4001 Basel
