Develop and maintain detailed timelines for regulatory activities and submissions, and assure planning and coordination of activities

Coordinate the content development process (planning, creation, review and approval) of selected regulatory documentation for inclusion in submissions to health authorities.

Compile regulatory submissions that meet MOH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.

Maintain regulatory archival database – ongoing update of database with regulatory submissions and correspondence. Development and implementation of SOPs and systems to track and manage product-associated events.

Participate in coordinating with external vendors supporting regulatory submission related tasks.

Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval.

Stay abreast of changes in the regulatory environment and guidelines in areas relevant to company projects.

Work with manager on acquisition and development of required regulatory skills and Knowledge.

Follow general instructions to complete projects. Organize workday to complete midterm assignments. Support other projects as directed.