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.
Senior Specialist Regulatory Operations
- Active support in the field of Regulatory Operations, including project planning and tracking, communication with clients and authorities
- Implementation of strategies for electronic submissions in the course of regulatory procedures for medicinal products (human and veterinary) and medical devices
- Consulting clients regarding implementation and optimization of electronic submissions and document management systems
- Assist the creation, compilation and validation of electronic submissions (e.g. eCTD, NeeS) for different types of regulatory activities (e.g. MAAs, PSUR, amendments, variations, renewals) in ICH and non-ICH-areas using available software
- Support planning, preparation, execution and tracking of projects in the context of Regulatory Information Management, incl. XEVMPD- and IDMP-related topics
- University degree in pharmacy or other natural sciences
- At least 1 year of professional experience in evaluation, preparation and compilation of quality dossiers and/or experience in regulatory processes (registration procedures, renewals, variation procedures) would be a significant advantage
- Structured, analytical, systematic and independent working manner
- Experienced user of the MS-Office package, Adobe Acrobat and database systems
- English language fluency, written and spoken
- Opportunity to conquier exciting and varied challenges alongside a talented team
- Flexible working hours
- Open and collaborative organisational culture with emphasis on knowledge-sharing
- Business interaction with nearly all branches of the company across 5 continents
- Broad range of initiatives for personal development and professional training.
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.