Regulatory Affairs Manager

Job Description

Job Summary:

• 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.

Duties & 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 Flux guard and CCDS/Safety Labeling Tracking.
• Support PV and RA inspections as it relates to safety labeling.
• Represent GRA function on PV Safety Signal Meeting.

Required Qualifications:

• Scientific knowledge.
• Ability to multitask and prioritize.
• Ability to work effectively in multinational/multicultural environment.
• Sound basis of Regulatory knowledge.
• Management skills.
• 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.

Required Education & 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.