We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Manager Regulatory Affairs CMC
- Evaluation and compilation of documents and sections regarding pharmaceutical quality (CMC).
- Preparation of documents related to ASMF, Certificates of Suitability', documents for IMPD, QOS/Expert Reports and Drug Product quality sections, as part of the compilation of the marketing authorization dossier.
- Participation in regulatory processes to gain and maintain of European and non-European marketing authorizations for human medicinal products (application, renewal, variations) with emphasis on pharmaceutical quality aspects.
- Provision of general guidance and consultancy to Pharmalex staff and clients regarding quality aspects from drug development up to life-cycle management.
- Participation and preparation of the informative texts for healthcare professionals and patients (SmPC, PIL, labelling) with view to quality related details.
- Contribution to Scientific Advice Meetings with regulatory authorities, concerning quality issues.
- Conduct of technical database, internet and literature searches with preparation and evaluation of the search results; review and evaluation of technical literature.
- Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field, ideally also a PhD or Master degree
- +3 years of experience in the field of Regulatory Affairs
- Knowledge of relevant legislative and non-legislative guidelines on Regulatory Affairs
- Familiarity with industry principles of Regulatory Affairs.
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global and local PharmaLex SOPs and Regulatory Affairs related SOPs.
- Experience in the technical tasks that are performed by the members of the Regulatory Affairs department.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.