RA Executive (1 year contract)

Job description

Job Description

Contributes to the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory approval across various therapeutic areas, in alignment with core business objectives.
• Prepares submission dossier for new drug applications and post-approval variations within agreed timeline. • Prepares monthly project status updates. • Maintains knowledge of latest regulatory requirements for therapeutic products. • Establish and maintain good working relationship with the HSA. • Acts as primary RA contact for the local team for the projects assigned. • Ensures new regulatory initiatives and changes are shared with the regional/global RA function in a timely manner with critical assessment of potential impact on business for the projects assigned under the guidance of the Regulatory Manager. • Develop and maintain database as required. • Maintain and update regulatory files and records as required. • Ensures compliance with local regulations, corporate policies and procedures. • Support process improvements and implementation of best practices. • Collaborates with local Quality Assurance (QA) on Quality matters (e.g. implementation of safety label changes). • Checks and ensures promotional materials comply with local regulatory requirements and corporate policies (if assigned).

Desired profile

Minimum requirements

A minimum of Bachelor’s degree in health-related sci-ence, life science, Pharmacy degree desired. English Executive: 1 to 2 years of experience in regulatory affairs,proven track record of preparing and reviewing regulatory documentation, and managing submissions successfully Good understanding of local regulatory environment, guidelines and processes for product registration. Ability to apply knowledge to general regulatory topics for projects assigned. Ability to work effectively independently and in a team. Computer literacy with knowledge of MS Office applications. Good interpersonal, organization, negotiation and problem solving skills. Excellent verbal and written communication skills. Able to work within a multidisciplinary and multi-culturally team environment and independently as individual contributor. Able to share concepts, ideas, information and suggestions with peers. Able to provide regulatory inputs to other departments. Able to manage multiple assignments and tasks, within tight timelines.