Manager Regulatory Affairs Cmc - Zaragoza, España - Pharmalex

Pharmalex

Empresa verificada

Zaragoza, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

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 lifecycle 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 pharmacyrelated field, ideally also a PhD or Master degree

- +3 years of experience in the field of Regulatory Affairs

Knowledge of relevant legislative and nonlegislative guidelines on Regulatory Affairs
Familiarity with industry principles of Regulatory Affairs.
Detailed knowledge regarding projectrelated SOPs (internal and clientspecific), 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.