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 Manager, Labelling & Regulatory Affairs
- Accountability for the execution of operational tasks in the field of Regulatory Affairs 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.
- Chairing or participation in multi-disciplinary labelling committee meetings
- 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)
- Provide inputs into the development and improvement of labelling processes
- Communication in the project team, with customers, local partners and authorities in an international context
- Presenting seminars and lectures for PharmaLex-internally, for customers and for a professional audience
- You have successfully completed a degree in pharmacy, medicine or other life sciences discipline
- You have experience in developing, implementing and operating labelling processes.
- You have relevant experience and have the capability to chair or participate in multidisciplinary labelling committees.
- You are a responsible communicator, who is able to articulate and defend complex labelling concepts in a suitable language for the prescriber and patient and with different client stakeholder departments (PV, Medical, Commercial etc.).
- You understand the considerations for label optimisation through TPP, product development and MAA processes, both pre- and post-authorisation.
- You have a strong knowledge of international labelling requirements and guidelines.
- You have a proactive approach and “can do” attitude to drive forward labelling processes and facilitate harmonisation of interests in multidisciplinary labelling committees.
- You have experience in drafting labelling decisions, including supporting information.
- You have a sound knowledge of current pharmaceutical and regulatory requirements (EU)
- You have experience in project management, you are multi-tasking capable, and enjoy consulting customers
- You are a team player, communicative, conscientious, accurate and responsible
- You are flexible and have a willingness to travel
- You are confident in the use of MS Excel and Word as well as business fluent in English skills
- 25 Days holiday plus BH (increasing to 27 after qualifying service)
- 8% employer pension contribution
- A role that is based in an excellent location with good public transport links and close to local amenities.
- 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 and salary expectations on-line.
To apply, please use the "apply now" button below
Agencies only by prior agreement for the specific job opportunity.