Regulatory Affairs CMC Project Lead coordinating multiple pharmaceutical projects at Sanofi. Providing strategic regulatory guidance, mentoring team members, and ensuring compliance in drug development.
PC
Hybrid Expert Compliance & Risk Consultant
Posted 3 months ago
About the role
- Compliance Maturity Model Expert providing expert-level guidance on compliance standards in Electric Compliance. Analyzing performance, performing gap analyses, and supporting mitigation plans.
Responsibilities
- Provides expertise to leadership and cross-functional teams regarding development, implementation, and monitoring of controls and mitigation plans.
- Develops compelling data-driven business cases for or against specific courses of action and potential risk mitigation alternatives as appropriate.
- May lead company response to regulatory data requests, investigations, audits, and other inquiries.
- Regularly updates leadership on changes to requirements/standards, metrics, program effectiveness, and opportunities for improvement.
- Lead root cause analysis exercises.
- May participate in risk management forums at the enterprise level.
- May act as team lead but does not have any direct reports.
Requirements
- Bachelor’s degree or equivalent experience
- 7+ years of relevant experience
- Experience within a regulated utility or electric compliance environment
- Familiarity with identifying, documenting, and/or testing controls, compliance data systems, and evidence management best practices
- Certified Compliance and Ethics Professional (CCEP), or
- Leading Professional in Ethics and Compliance (LPEC), or
- Certified Internal Auditor (CIA), or
- Certified Information Systems Auditor (CISA), or
- Certified Information Security Manager (CISM), or
- Certified Risk Management Professional (RIMS-CRMP), or
- Other compliance or risk related certification, as applicable
- Ability to influence others to achieve understanding, acceptance, and commitment to act
- Highly flexible, self-directed, and able to adapt well to a rapidly changing environment
- Advanced knowledge of California and federal regulatory requirements and electric utility compliance practices
- Proven ability to analyze complex compliance or risk issues and translate findings into clear recommendations
- Strong analytical, problem-solving, project/change management, and communication skills, including experience presenting to senior leaders.
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Discretionary incentive compensation programs
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