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 CMC
In this position you will have accountability for the execution of operational tasks in the field of Regulatory CMC that require established experience and specific scientific expertise in the sector of human and veterinary medicinal products with special emphasis on the relevant European regulatory requirements.
- 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.
- Participation in regulatory processes to gain and maintain of European and non-European marketing authorisations for human medicinal products (application, renewal, variations) with emphasis on pharmaceutical quality/CMC aspects.
- General guidance (consultancy) of PharmaLex staff and customers regarding quality aspects of drug product development and life-cycle management.
- Conduct of technical database, internet and literature searches with preparation and evaluation of the search results, review and evaluation of technical literature.
- 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, prioritisation and processing of parallel projects and tasks
- High service orientation
- Excellent organisation skills
- 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 and various regulatory systems
- English language fluency, written and spoken
- 25 days holiday plus bank holidays (increasing to 27 days after qualifying service)
- 8% employer pension contribution
- The role can be based at any of our UK locations with flexibility to work remotely
- 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 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:
Manager, Human Resources UK
Agencies only by prior agreement for the specific job opportunity.