Regulatory Affairs Manager

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.
3 days onsite required/2 days remote
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
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
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.
Max Bill Rate: ***/hour
SUPPLIER SPOTLIGHT CALL - Thursday 10/22 at 10: 30am CST
Please join the call 5 minutes early.
Microsoft Teams meeting
Join: https://teams.Microsoft.Com/meet/***28284? P=zLc1PGiWDC0O14yrhr
Meeting ID: ***28 284
Passcode: XQ3iL6qx
Need help? | System reference
Dial in by phone
[a id="x_meet_invite_block.Action.Join_phone_number1" href="tel:+***, 154763049#" target="_blank" rel="noopener noreferrer" data-auth="NotApplicable"]+***, 154763049# United States, Waukegan
Find a local number
Phone conference ID: 154 763 049#
Join on a video conferencing device
Tenant key: ***
Video ID: 119 200 542 8