Regulatory Associate
Regulatory Associate
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Research & Monitoring Proficiency.
- Ability to synthesize large volumes of information into concise actionable insights.
- Ability to create reports and alerts for crossfunctional teams.
- The Sr Associate Regulatory Intelligence role performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs.
- Uses internal and external contacts tools and systems to gather regulatory intelligence.
- Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback.
- Works with limited supervision according to predefined regulatory intelligence workplans.
- Applies tools and systems to deliver agreed intelligence objectives.
- Communicates progress and escalates issues impacting delivery of intelligence outputs.
- Identify and document key regulatory requirements for global submissions.
- Track updates from global regulatory authorities (e.g. FDA EMA MHRA PMDA TGA) and internal contacts.
- Monitor industry newsletters journals press releases and competitor activity.
- Set alerts in regulatory intelligence platforms (e.g. Cortellis IQVIA) for new guidances legislation or enforcement trends.
- Maintain a centralized regulatory intelligence repository (e.g. SharePoint internal dashboards).
- Ensure historical tracking and tagging of relevant changes for future reference
- Communication & Reporting.
- Draft and distribute regulatory intelligence newsletters or briefs.
- Prepare summaries or presentations on key changes.
- Update internal stakeholders (Regulatory Affairs Quality Clinical R&D etc. on highimpact developments.
- Regulatory Knowledge & Analytical Thinking.
- Strong understanding of global regulatory frameworks (FDA EMA ICH etc.. Ability to interpret complex regulatory texts guidance documents and policy updates.
- Experience in using regulatory intelligence tools and databases (e.g. Cortellis Informa IQVIA).
- Continuous scanning of health authority websites publications and competitor activity.
- Communication & Strategic Influence.
- Strong written and verbal communication skills to translate regulatory developments into clear guidance.
- Database & Knowledge Management.
Employment Type
Full Time
