Regulatory Affairs Associate
vor 2 Monaten
Für ein biopharmazeutisches Unternehmen in München suchen wir zum nächstmöglichen Zeitpunkt eine/n
**Regulatory Affairs Associate (m/w/d)**
Supports the activities of the affiliate's Regulatory Affairs team to ensure that the company complies with country's applicable legislations and regulations pertaining to the portfolio (at all stages of the product's life cycle), i.e. ensure that the medicinal products can be developed, authorized and maintained on the market.
Essential Duties and Responsibilities:
- Support local (deputy) representatives (QA/GDP Responsible Person and deputy) as required by local law to support maintenance of GDP license and Quality Agreements as required including but not limited to;
- management of quality complaints, quality defects, falsified or counterfeit products, batch recalls, and stock out as required.
- management of Quality systems inc. data entries.
- maintenance and update of procedural documents
- Support Regulatory Team when required;
- to ensure compliant labeling for the medicinal products and manage timely updates
- to provide operational support to Reg Team with creation, review and release of German Compendia and Basistext (already being supported by a local vendor partially or-ad-hoc)
Knowledge, Experience & Skills:
- preferred: 2-3+ years of experience in Regulatory Affairs (RA) or Quality Assurance (in the field of GDP is preferred) with BS/BA Degree in a scientific field
- Basic knowledge and experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local affiliate
- advantageous: Knowledge in promotional and non-promotional review as well as pharmacovigilance and market access
- beneficial: Experience in working with project teams
- Ability to work on a number of projects with tight timelines
- Excellent verbal and written English and German language skills, organization skills and interpersonal communication skills required
Parameter:
- Standort: München (vsl. 3 Tage vor Ort, 2 Tage remote möglich)
- Start: zum nächstmöglichen Zeitpunkt
- Auslastung: Vollzeit (38h/Woche)
Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.
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