Regulatory Affairs Manager(Hybrid)

Job Title: Regulatory Affairs Manager
Location: Deerfield, IL, 60015 (3 days onsite required/2 days remote)
Duration: 12 months

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 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

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.

Himanshu Goswami

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: Himanshu.goswami
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