Local safety administrator & regulatory affairs specialist

POSITION SUMMARY:

This role combines Local Safety Admnistrator (50%) and Pharmakovigilance agenda (50%). Under supervision of the Head and the RAM, the RAP s responsible for regulatory activities to support and grow the business in line with the company goals. This includes:

• Support in obtaining and maintaining marketing authorizations.
• Contribute to fast introduction of new products and line extensions including new indications
• Ensure regulatory compliance

ESSENTIAL DUTIES AND RESPONSIBILITIES

Departmental management
• Handling incoming and outgoing correspondences, including archiving.
• Maintain the local product files in line with current registered authorization details according to the relevant local and EU legislation.

New and existing products
• Prepare and submit regulatory submissions with support from regulatory operations.
• Ensure deadlines for different projects are met or escalated to Regulatory manager and/or Head of RA.
• Participate in internal (e.g. LLCM) working groups as required and address any regulatory actions with senior RA colleagues.
• Maintain the product label and packaging in line with current registered authorization details according to the relevant local and EU legislation

Compliance
• Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems …)
• Maintain an awareness of regulatory guidelines/directives/national requirements.

Internal contacts
• Support other departments based on their needs (logistic, quality, pricing, medical, marketing, sales)
• Support tender business

External contacts
Ensure positive interaction in any communication with the local health authority, in general and on product-specific topics.

Miscellaneous
• Support and contribute to GRA-EMEA initiatives
• Contribute to initiatives around lessons learnt and change management to ensure efficiency gains.
• Pack-mat activities
• Administrative support of PhV department