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
- Participation in regulatory processes to gain and maintain European and non-European marketing authorizations for human and veterinary medicinal products (application, renewal, variations)
- 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 PharmaLex-internally, 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 client-based 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
- 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
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.