I am currently in the search for a Regulatory Affairs Manager with experience in the Pharmaceutical (Combination Product) sector

Your tasks

• Approval strategies for combi products

• Maintenance of existing approvals for combi products

• Variation notifications

• Choice of new drug suppliers

• Interface management to health authorities both inside and outside Europe, but also globally

• Creation and maintenance of Common Technical Documents for Combination Products (eCTD)

• Consult the responsible R & D managers in the development and validation of new combination products

• Independent updating / development and implementation of measures for new requirements for combination

products at home and abroad

your qualification

• Successfully completed pharmaceutical or natural sciences studies or equivalent qualification

• Several years of professional experience in the authorization of pharmaceutical products or combination products

• Sound knowledge in the creation of eCTDs

• Negotiation skills and communication skills

• Strategic, analytical, entrepreneurial thinking

• Very good knowledge of English in spoken and written English

• Ability to work with MS Office