Description
My client a global company is seeking a EMEA Regulatory Affairs Specialist to join their team.
As the EMEA Regulatory Affairs Specialist you will be responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorisations (for products) and communication of general regulatory requirements in support of licensing of my client's products. Serves as a consultant to managers.
Key skills and experience.
*Compile and submit in a timely manner, regulatory documents according to regulatory requirements.
*Prepare review and approve labelling and SOP's. Assist lower level team members on complex issues.
*Provide regulatory advice to project teams.
*Respond to regulatory authority's questions with strict deadlines.
*Maintain regulatory files in a format consistent with requirements.
* Develop and initiate complex regulatory project plans.
*Manage regulatory activities relating to specific portfolio of products/projects (product owner).
*Maintain and update existing regulatory authorisations.
*review promotional material for compliance with local regulations.
*Experience with regulatory or equivalent experience within a pharmaceutical company CRO, or similar organisation.
* Technical systems skills (eg word processing, spreadsheets, databases, online research).
*Experience of managing multiple projects and deadlines.
*Ability to identify compliance risks and escalate when necessary.