Company
Biotech
RegulatoryAffairsConsultant-RegulatoryPartnerResponsible
Neural analysis suggests this role is
optimal for Senior candidates.
“Regulatory Affairs Consultant- Regulatory Partner Responsible. Skills: Regulatory affairs, Compliance oversight, Partner governance. Provide oversight of regulatory partner activities. Ensure compliance with local regulations”
What You'll Achieve.
Improve regulatory quality; Improve healthcare outcomes
Industry & Context.
Issue resolution; Risk identification; Root cause analysis
What They're Looking For.
Must Have
5+ years experience in Regulatory Affairs, 5+ years experience in compliance, 5+ years experience in governance, Proven experience in partner management, Proven experience in vendor management, Understanding of regulatory frameworks, Understanding of compliance requirements, Understanding of quality systems in life sciences, Ability to operate in a matrixed organization, Ability to operate with multiple stakeholders, Ability to operate with multiple priorities, Analytical mindset, Ability to identify risks, Ability to implement controls, Ability to drive process improvements
Nice to Have
Degree in Life Sciences preferred, Degree in Pharmacy preferred, Degree in related scientific discipline preferred
What You'll Do.
Provide oversight of regulatory partner activities
Ensure compliance with local regulations
Ensure compliance with internal standards
Ensure compliance with governance frameworks
Monitor partner performance against KPIs
Identify deviations in partner performance
Drive corrective actions
Drive preventive actions
Act as primary contact for escalations
Act as primary contact for issue resolution
Act as primary contact for governance
Ensure alignment with local regulatory requirements
Communicate regulatory updates to internal teams
Communicate regulatory updates to cross-functional teams
Support regional regulatory teams in planning
Support regional regulatory teams in preparing submissions
Maintain internal regulatory databases
Update internal regulatory databases
Ensure accuracy of compliance tracking
Ensure accuracy of performance indicators
Foster relationships with external partners
Ensure adherence to company regulatory expectations
Ensure adherence to company regulatory standards
Oversee training effectiveness for partners
Ensure compliance capability development
Ensure continuous improvement in compliance
How You'll Work.
Team & Collaboration
Cross-functional teams; Diverse stakeholders
Communication Scope
Communicate updates
Full Job Description
## Accountabilities Provide end-to-end oversight of regulatory partner activities, ensuring compliance with local regulations, internal standards, and governance frameworks. Monitor partner performance against defined KPIs, identifying deviations and driving timely corrective and preventive actions. Act as the primary point of contact for escalations, issue resolution, and governance related to external regulatory partners. Ensure alignment with evolving local regulatory requirements and communicate updates to internal GRA and cross-functional teams. Support regional regulatory teams in planning and preparing submissions in accordance with local business and regulatory needs. Maintain and update internal regulatory databases, ensuring accuracy of compliance tracking and performance indicators. Foster strong relationships with external partners while ensuring adherence to company regulatory expectations and standards. Oversee training effectiveness for partners, ensuring appropriate compliance capability development and continuous improvement. Requirements: 5+ years of experience in Regulatory Affairs, compliance, governance, or related roles within pharmaceutical, biotechnology, or healthcare industries. Proven experience in partner or vendor management, including oversight of third-party regulatory activities. Strong understanding of regulatory frameworks, compliance requirements, and quality systems in life sciences. Ability to operate effectively in a matrixed, global organization with multiple stakeholders and priorities. Strong communication, influencing, and stakeholder management skills across diverse cultural and functional environments. Analytical mindset with the ability to identify risks, implement controls, and drive process improvements. Degree in Life Sciences, Pharmacy, or a related scientific discipline preferred. Benefits: Opportunity to work in a global regulatory environment with high-impact responsibilities. Exposure to cross-regional regulatory
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