Project Leader Regulatory Affairs EMEA
Location: NetherlandsThe Apotex Europe Regulatory Affairs team is responsible for the operations and management of regulatory activities pertaining to medicinal products under development (New Product Development: NPD) or sourced from 3rd parties (NP) as well as those registered (Product Life Cycle Management: PLCM) in the countries of the European Economic Area (EU Member States plus Liechtenstein, Iceland and Norway), European CIS region, Middle East & Africa. The Regulatory Affairs team plays a key role in providing technical and scientific advice, support and service to R&D, Quality, Sales & Marketing and Portfolio functions in the development of effective regulatory strategies and has significant interaction with all relevant competent Regulatory Bodies. The team also interacts with the relevant departments within the Apotex organisation as well all external partners (commercial partners as well as service providers) in the countries concerned to ensure that applications are dispatched, submitted and approvals are granted in a timely manner.
The company
The Regulatory Affairs team plays a key role in providing technical and scientific advice, support and service to R&D, Quality, Sales & Marketing and Portfolio functions in the development of effective regulatory strategies and has significant interaction with all relevant competent Regulatory Bodies. The team also interacts with the relevant departments within the Apotex organisation as well all external partners (commercial partners as well as service providers) in the countries concerned to ensure that applications are dispatched, submitted and approvals are granted in a timely manner.
Role description
Responsible for providing project leadership and oversight to ensure smooth and efficient processes leading to timely submission of variations and timely approvals to achieve optimal moment of implementation of the change of address for selected products for Marketing Authorization Holder (MAH) Apotex Europe BV (AEBV) with maximal synergy for changes required to implement the Falsified Medicines Directive (Unique Identifier & QRD Updates) for selected markets integrate the overall change in artwork design into the project. You will report to the Head of RA, Europe & Middle East.
- Responsible for support to achieve optimization of the processes pertaining to coordination and timely submissions, approvals and implementation of the address change for MAH AEBV incl. EU central, de-central, mutual recognition and national application procedures
- Create and execute plans, reporting and revision as appropriate to meet changing business & RA requirements
- Ensure maximal synergy in planning and implementation to achieve optimal costs and tight expense control
- Provide appropriate and timely reports as per Project Governance
Responsibilities
- University degree or equivalent in Chemistry, Pharmacy or Life Science
- Minimum of 5 years’ experience in pharmaceutical industry with at least 3 years' in Regulatory Affairs
- Familiarity with European and EMEA region regulatory requirements
- Computer literate
- Good written/spoken communication, organisational and interpersonal skills
- Good in spoken and written English, any other European language would be an asset
Acquisition by third parties is not appreciated.
