- Preparation and submission of MRP/DCP/NAT variations (chemical, manufacturing, control, clinical or safety related)
- Management and maintenance of labeling documents throughout the product life cycle.
- PAC and RTQ submissions, other communications with RA
- Product license cancellations
- Archiving regulatory documents
- Management of local regulatory databases and systems and keep global regulatory platforms updated with Greek registered details as appropriate
- Interface with competent authorities and central groups on regulatory matters
- Artwork development and timely implementation of artwork changes
- Compliance with company policies and local legislation
- Work collaboratively with local Quality, Medical, Commercial, Supply teams to ensure overall business and department objectives are met
- Support of repackaging activities as required
- Work on individual projects as required
experience - 1-3 years Regulatory Affairs experience in a pharmaceutical company
qualifications - Life Science Bachelor Degree (pharmacist, biologist, chemist)
- Excellent Knowledge of the English language
- Computer literacy
- Good knowledge of Local, EU and International regulatory affairs legislation and guidance
- Good written communication skills with attention to detail
- Team working skills
- Strong critical thinking and ability of data interpretation
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Quality Assurance Analyst
Βρέθηκε σε: beBee S2 GR - πριν 1 μέρα
Teva Pharmaceuticals Athens, ΕλλάδαWho we are · Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries de ...
Regulatory Affairs CW - Athens, Ελλάδα - Randstad Hellas
Περιγραφή
Do you acquire experience within the Regulatory Affairs sector? Is working in one of the most well established multinational companies a career goal for you? If the answer is yes, then look no further
We have the ideal job for you.
Our client is looking for an experienced and skilled professional to join the Regulatory Affairs department as a Regulatory Affairs CW.
key responsibilities