Bachelor's degree in a scientific discipline; Master's or PhD preferred
Minimum 5 years of regulatory experience in Regulatory Affairs or related field
Strong understanding of regulatory compliance and safety labeling processes
Ability to multitask and prioritize in a fast-paced environment
Proven experience managing complex projects and timelines
Excellent interpersonal, communication, and presentation skills
Demonstrated negotiation skills and ability to lead and coach others
Responsibilities
Serve as the key interface between Pharmacovigilance, Regulatory Affairs Labeling Team, and Global Labeling Operations
Establish and oversee safety labeling processes for Global Regulatory Affairs
Monitor and manage generic labeling and innovator label variations
Lead continuous improvement initiatives and KPI reporting for safety labeling metrics
Ensure compliance oversight of safety-related labeling changes across global markets
Develop training materials to enhance safety variation submission processes
Support inspections related to safety labeling and represent the GRA function in safety signal meetings
Benefits
Opportunity to work in a multinational and multicultural environment
Engagement in continuous improvement initiatives
Professional development through training material creation
Exposure to global regulatory compliance processes
Collaboration with cross-functional teams in a dynamic setting
Full Job Description
Job Description: 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. Essential Duties and Responsibilities :
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 Client'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
Qualifications :
Scientific knowledge
bility to multitask and prioritize
bility to work effectively in multinational/multicultural environment
Sound basis of Regulatory knowledge
bility 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
bility to lead and coach others
bility to independently identify compliance risks and escalate when necessary
Education and/or Experience:
Bachelor's degree or country equivalent in a scientific discipline
Masters and/or PhD will be an advantage.
Minimum of 5-year regulatory experience in RA or related field, including managing people or projects.
