Responsible for strategic oversight of safety related labeling variations impacting regulated pharmaceutical drug products while ensuring regulatory compliance, patient safety, and consistent communication of product information across global markets.
- Scientific knowledge
- Ability to multitask and prioritize
- Ability to work effectively in multinational/multicultural environment
- Sound basis of Regulatory knowledge
- Ability to manage complex projects and timelines in a matrix team environment
- Strong interpersonal, communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
- Technical and management skills
- Ability to lead and coach others
- Ability to independently identify compliance risks and escalate when necessary
Education and/or Experience:
- Bachelor's degree or Pharmacy, Pharmaceutical Sciences, Life Sciences, Biomedical SciencesMasters and/or PhD will be an advantage.
- Minimum of 5-year regulatory experience in RA or related field, including managing people or projects.
- This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
- Key Interface between Pharmacovigilance (PV), Regulatory Affairs Labeling Team and Global Labeling Operations
- Ownership and Establishment of Safety Labeling Processes for GRA including but not limited to:
- CCDS and associated Safety Variations
- Generic Labeling and Monitoring of Innovator Labels
- PRAC and MOH triggers
- Oversee generic labeling surveillance and innovator-label monitoring
- Oversee PRAC recommendations
- Lead continuous improvement and KPI reporting including but not limited to CCDS metrics including coordination of NCR's
- Safety labeling governance and compliance oversight of safety related labeling changes across global markets (i.e., escalate risks associated with overdue safety variations)
- Develop Training Materials for improved safety variation submission process and related system changes
- System Owner for Fluxguard and CCDS/Safety Labeling Tracking
- Support PV and RA inspections as it relates to safety labeling
- Represent GRA function on PV Safety Signal Meeting