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.
Regulatory Affairs Manager
- Accountable for the execution of operational tasks in the field of Regulatory Affairs mainly in the field of Regulatory Submissions that requires established experience and specific scientific expertise in the sector of human and veterinary medicinal products with special emphasis on the relevant European regulatory requirements.
- Leader for the co-ordination of projects where PharmaLex has been commissioned to take over comprehensive Regulatory Affairs responsibility for a company’s medicinal product(s) in the pre-approval and post-approval phase.
- Organisational leadership and professional supervision of a Regulatory Affairs team.
- Responsible for implementing operational tasks in the field of Regulatory Affairs.
- Work independently with strong commitment to task.
- 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 and Labelling
- Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labeling)
- Responsible for the planning, filing and prosecution of projects. Manage the maximum production capacity to meet peak workloads and project deadlines. Responsibility for the working organisation within the department incl. assignment of defined tasks to the team employees
- Creation, revision, editing and maintenance of regulatory documentation.
- Communication and implementation of decisions of the general management and RA Heads (Local and global). General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labeling
- Representation of the company and the team with clients, authorities and professional institutions.
- Contribution to optimizing departmental internal processes. Design and prepare Standard Operational Procedures, Working instructions and Client Specifications for Regulatory Affairs processes; ongoing revisions and implementing updates.
- Active contribution and distribution of department relevant expertise.
- Presenting seminars and lectures PharmaLex-internally, for customers and for professional audience
- Ensure client satisfaction and compliance with legal and regulatory requirements.
- Creation of a motivational working environment. Implementation of the leadership culture in close cooperation with the Heads of the Regulatory Affairs and other departments.
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.
For further information please don’t hesitate to contact us:
Senior Specialist, Human Resources
Agencies only by prior agreement for the specific job opportunity.