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USA - Regulatory Affairs Manager
Mindlance
- 🇺🇸 United States
- On-site
- Manager or above
- 12 hours ago
- Regulatory Compliance
12 hours ago
Not enough detail in this posting to match
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
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Phone conference ID: 154 763 049#
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Tenant key: ***
Video ID: 119 200 542 8
EEO
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
USA - Regulatory Affairs Manager · Mindlance