Key Responsibilities:
* Fulfill industry and regulatory requirements.
* Handle communications with Competent Authorities for Authorized Representative duties.
* Contribute to Regulatory Affairs activities, ensuring timely approval of regulatory submissions and global compliance.
* Provide guidance on regulatory development and new product evaluations.
* Collaborate between regulatory, clinical, and quality assurance teams.
Responsibilities:
* Prepare Part 1 and CMC/Part 2 files for Marketing authorisation dossiers.
* Manage Pharma regulatory affairs, including experience in Industry and/or a regulatory agency/notified body.
* Understand Pharmaceutical regulatory guidelines and standards.
* Support product life cycle regulatory issues, including post-marketing changes.
* Create and oversee studies needed for dossier preparation.
* Provide technical input for pharmaceutical studies.
* Liaise with CMO's, API suppliers, CRO's on regulatory matters.
* Join project teams for new product development.
Requirements:
* Demonstrate expertise in EU Pharmaceutical Sector regulations.
* Possess four years of professional experience in regulatory affairs or quality management systems.
* Show ability to work independently and complete multiple assignments on time.