Description
We are looking for a
Regulator Affairs Associate 100% (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Basel region
Branche: Grosshandel mit pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Supporting affiliate RA colleagues in properly and timely registration in target countries
- Supporting maintenance of worldwide marketing authorizations, i.e. license renewals, CMC-changes, labeling changes
- Ensuring that all maintenance activities are managed and tracked in Synaps (BCC workflow tracking tool)
- Creating dossier content where applicable
- Compiling dossier information into a final deliverable
- Aligning activity and effort with the regulatory strategy
- Ensuring that all registration data are entered into the proper data management systems
- Compiling status reports
- Following appropriate IRA business policies, processes and standard operating procedures
- Ensuring that activities, plans, strategies, and outcomes are aligned with Product Supply
- Consumer Care, Product Development (PD) and/or Global Technical Regulatory Affairs
- (GTRA), Global Drug Safety (GDS), Medical Affairs and New Product Development (NPD) team as appropriate
- Possibility to Work 2 days Home-office and 3 in-office
Ihre Qualifikation
- A degree in life sciences
- Strong experience in comparable position
- Proven regulatory experience in consumer health care (ideally OTC, medical devices, cosmetics, food supplements)
- Knowledge and practical experience with European regulatory procedures; Mutual Recognition, Decentralized and National; knowledge and experience with other legislations is an asset
- Ability to articulate and formulate solutions to regulatory issues
- Proficiency in MS Office: Word, Excel, PowerPoint
- Ability to communicate effectively in English both verbally and in writing
- Ability to work as a member of a team
Skills:
- Regulatory affairs associate
Keywords: Regulator Affairs Associate 6 MM maintenance 100%freelance contractor freelancer contract contr contracting self-employed project Projekt