What are the responsibilities and job description for the Regulatory Associate position at cGxPServe?
Responsibilities:
- Research & Monitoring Proficiency.
- Ability to synthesize large volumes of information into concise, actionable insights.
- Ability to create reports, and alerts for cross-functional 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 guidance's, 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 high-impact 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.
