Regs Affairs Manager - Berlin - Pharma
NonStop are looking to speak with Regulatory Professionals, interested to work in Berlin , we currently have an opportunity for an on at least a 12 month contract, with one of the major players of the industry. Currently they are gaining traction in the market as the one to watch allowing you to gain huge exposure with a recognised name, giving yourself future opportunities for growth.
Scope and tasks:
- Responsibility for applying for and maintaining approvals, approved in the national, MRP and DCP procedures (including application, variations, PSUR submission, PSURs / PBRERs and risk management plans, etc.)
- Processing of all national processes in the CP
- Development of strategic inputs for all products
- Contact person for national approval and supervisory authorities, etc. a. Answering letters of deficiency, queries or calls
- Translation, creation and updating of SmPCs, technical and usage information and labelling, training materials and mandatory texts in accordance with national / European regulations and their approval (in close cooperation with Global and European RegAffairs, PV, medicine, marketing.
- At least 3 years of professional experience in regulatory affairs in a pharmaceutical company
Key skills, skills and competencies
- Knowledge of German on a native level and very good knowledge of English
- Excellent knowledge of the national legal bases for human medicinal products (AMG, HWG) and the other European bases and guidelines
- Scientific knowledge of the clinical development and approval of drugs and medical devices
- Good knowledge of dossier preparation; familiar with eCTD modules
- Basic product knowledge including basic medical knowledge about drugs
Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstop-recruitment.com or +41 435 080 817, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
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