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
Accountability for the execution of operational tasks in the field of Regulatory Submissions and Labelling 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.
- 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 & Labelling
- Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling)
- 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.
- Evaluation, preparation and compilation of documents and sections regarding pharmaceutical quality. This includes Active Substance Master Files, application documents for 'Certificates of Suitability', documents for Investigational Medicinal Product Dossier and Quality Overall Summaries/Expert Reports for human and veterinary medicinal products as part of the compilation of the marketing authorisation dossier. Strong emphasis on relevant technical and regulatory requirements and customer specific demands.
- 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 and quotation for Regulatory Affairs Projects in close cooperation with the respective team lead
- University degree in pharmacy or other natural sciences
- Proven experience 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
- 25 Days holiday plus BH (increasing to 27 after qualifying service)
- 8% employer pension contribution
- The role can be based at any of our UK locations.
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as 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 receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
To apply, please use the "apply now" button below
Agencies only by prior agreement for the specific job opportunity.