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 Affairs
This role will give you an opportunity to broaden your experience in a variety of regulatory tasks. You will assist the project leaders and the Senior Management in Regulatory Affairs at PharmaLex in all aspects of office and project management and in operational tasks.
- Support with preparation of documents within the framework of regulatory affairs projects European (CP, MRP, DCP, renewals, variations, and country-specific procedures) and non-European in agreement with projects leads
- Support with project work (e.g. compilation, preparation and reviewing of documents) after adequate instruction
- Support with preparation and handling of internal and external correspondence
- Technical organisation of training sessions, meetings, client visits etc.
- In agreement with Senior Management, Regulatory Affairs providing on-site regulatory support to PharmaLex clients.
- Maintain internal departmental templates
- Assist the project managers in project planning and organization of meetings
- Assist the Senior Management.
- University degree in pharmacy or other natural sciences
- Perennial experience or capability in area of activity or similar field (e.g. Regulatory Affairs, Pharmacovigilance, HR, Finance…); advanced knowledge and insights required to perform processes very efficiently and proven potential to take over more complex tasks
- Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
- Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision
- Ability to analyse and solve problems and to offer solutions for a given task or project; Attention to detail. High service orientation
- Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
- Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
- Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance.
- 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.