Manager Regulatory Affairs - 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

Your Job

General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labeling
Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labeling)
Presenting seminars and lectures PharmaLexinternally, for customers and for professional audience
Responsible for the planning, filing and prosecution of approval projects.
Creation, revision, editing and maintenance of regulatory documentation.
Planning and expediting the approval projects using the internally available or clientbased software tools.
Communication with the client and the Health Authorities.
Coordination of project teams with internal and external staff and RegNet Partners.
Contribution to optimizing departmental internal processes.
Active contribution and distribution of department relevant expertise.
If applicable support in preparation, quotation and invoicing for Regulatory Affairs Projects in close cooperation with the respective Team Lead

Your Profile

University degree in pharmacy or other natural sciences
Proven experience (+4 years) in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on quality aspects
Ability to implement tactical goals of customer or internal projects within daily work
Structured, analytical, systematic and independent manner
Capability of supervision, prioritization and processing of parallel projects and tasks
High service orientation
Ability to manage internal and external (client) relationships on operational as well as client's team lead level
Excellent team player
Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
English language fluency, written and spoken

Agencies only by prior agreement for the specific job opportunity.