Are you looking for a new challenge in an important and strategic role for an international pharmaceutical company?
Do you have experience as a head of regulatory affairs or as a regulatory team lead?
Then please read the job description below:
For my customer, an international pharmaceutical company with offices in NRW, I am currently looking for a Head of Regulatory Affairs.
In this role you will be responsible for overseeing all activities related to the marketing authorisation of a product that is currently being transferred to the company. The head of regulatory affairs' main responsibilities will be to oversee the outsourced and in-house functions working to maintain the marketing authorisation. They will also be the main point of communication with the relevant European health authorities.
- Manage outsourced and in-house functions in order to ensure compliance to relevant European regulations and requirements as well as defined service standards. The functions encompass:
- Regulatory affairs
- Product quality assurance
- Pharmacovigilance Manufacturing and logistics
- Set-up the outsourcing of required functions in collaboration with corporate departments (legal and/or HR) and define quality and performance indicators for each function
- Monitor and report on any non-compliances, risks and issues related to the outsourced functions
Health Authority Communication and Reporting:
- Responsible for timely and accurate communication with the relevant health authorities in Europe
- Regular reporting to the headquarters on all relevant topics
- Ad-hoc reporting in case of non-compliances
Management of Systems, Processes and Capability:
- Define and drive the implementation and optimization of:
- Required systems (e.g. PV Master File), with the support of the relevant PV roles
- Processes and their documentation (e.g. Standard Operating Procedures, KPIs/ KQIs)
- Update above in line with new regulatory requirements with the support of the Regulatory Affairs roles
- Develop a long-term strategy to integrate the marketing authorisation relevant roles into the business and gain approval from the company's headquarters
- Implement long-term strategy by recruiting relevant roles in collaboration with corporate functions
This is an exciting opportunity to work for an international pharmaceutical company with innovative products.
This position requires a highly motivated and driven individual, who would like to recruit and develop a team of regulatory experts.
The next step:
If you are interested in this position and would like to apply, then please send me your CV and salary expectations.
Andrew Pride - Principal Consultant Regulatory Affairs
T: +49 (0) 89 - 551 977 67
Progressive München - Pharma