The Roles & Responsibilities include;
Regulatory Strategy
- Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
- Collects and evaluates information on regulatory requirements for quality preclinical and clinical data to meet applicable regulations.
- Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority seeking opportunities to expedite regulatory approvals where possible.
- Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements
Regulatory Compliance
- Initiates reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
- Identifies & initiates local process improvement opportunities and manage changes as required
Qualifications :
- Knowledge of consumer healthcare environment and product development
- Understanding of processes and departments within a healthcare company
- Effective time and organisation management
- Excellent communication skills with the ability to articulate and express concepts clearly both verbally and in writing particularly when simplifying complex regulatory or technical issues.
- Good interpersonal skills; able to build effective personal networks internally and externally.
- Collaborative with a strong sense of ownership willing to be held accountable and be rewarded for delivering results.
- Strong organizational and time management skills with an ability to work under pressure.
- Able to work effectively in a multi-cultural highly matrixed organization
- Proficiency in English
Remote Work :
Yes
Employment Type :
Contract