Manager Regulatory Affairs Cmc
hace 1 semana
**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**
**Your Job**
- 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.
- 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.
The employee agrees to carry out any other reasonable tasks that are correspondent with their abilities if asked by the general management.
**Your Profile**
- 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.
Agencies only by prior agreement for the specific job opportunity.
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