Regulatory Affairs Specialist/EMEA
A large biotechnology company is recruiting an experienced Regulatory Specialist EMEA in Germany. You will be responsible for preparation and maintenance of registration files as well as for executing tasks related to the administrative processes of product registrations.
- Under direction of the supervisor compile and maintain registration files for countries in EMEA.
- Support in timely registration of new products and maintenance of registered product license in countries assigned by the supervisor.
- Execute administrative tasks related to the product registration process
- Support the business in obtaining on-time documents required to import/export products or to obtain reimbursement
- Communicate with consultants, agents, distributors or other stakeholders in relation to registrations in process
- Other activities as needed assigned by the supervisor in support of regulatory processes and/or registrations
Skills and Requirements
- Preferably a Bachelor (Hochschule) or University Degree in Science, Engineering, and/or Biotechnology or equivalent relevant experience
- Minimum 2 year experience in Regulatory Affairs in Medical Device/Pharmaceutical industry in EMEA, preferably in a multi-cultural environment
- * Experience with handling regulatory files and submission processes
- * Excellent interpersonal and communication skills
- * Able to work independently
- * Meticulous and attention to details
- * Good English communication skills verbally and in writing
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.