We are representing a top, global Consulting firm in their search for a Senior-level (Director or Senior Director) Life Sciences Regulatory Compliance Officer who will be responsible for developing and leading the strategic regulatory compliance program for their Life Sciences business unit in order to meet global regulatory requirements pertinent to the company’s services and software products.
Expectations:
- You will have a strong R&D/pharma/Contract Research Organization (CRO)/life science compliance background and experience working with new and emerging technologies.
- You will also possess solid project and portfolio management skills and the ability to work at a senior level with client compliance and operations business stakeholders.
- The Life Sciences Regulatory Compliance Officer should be a strategic-thinker and a natural team player who has demonstrated their capacity to succeed in collaborative work scenarios involving risk, privacy, legal, compliance and operation professionals.
- You will have a strong knowledge of Life Science lines of business to include, but are not limited to Life Sciences’ Software Products and Platforms, Business Process Outsourcing (BPO) and Business Process as a Service (BPaaS) and their respective component services.
- Laws and Regulations: include but are not limited to GxP, 21 CFR Part 11/Annex 11, medical device and data privacy as these pertain to the EU, UK, US, Japan and other global regulatory agencies and authorities.
Responsibilities:
- Develop, implement and manage a regulatory compliance program as required for some or all of:
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- Life Sciences component services (BPO, BPaaS, PaaS, SaaS delivery models)
- Life Sciences Products and Platforms lines of business and other tools used in support of regulated activities
- Life Sciences infrastructure / enterprise systems
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- Provide thorough oversight, internal advisory/consulting and monitoring/reporting activities to ensure compliance with all applicable global regulations for all Life Sciences lines of business.
- Work with executive and senior management on strategic and operational planning activities to ensure compliance with all applicable global, US federal, state laws and regulations.
- Ensure identified compliance risks are mitigated/remediated.
- Interface with compliance professionals across Company domains to ensure that Life Sciences lines of business conform to applicable laws and regulations globally as well as to all Company Corporate Compliance standards, policies, and practices.
- Assess and manage regulatory risk across all Life Sciences lines of business.
- Manage the Life Sciences implementation of new laws and regulations affecting regulated activities and products. Review the Company’s Life Sciences operations for adherence to compliant policies and procedures.
- Interpret and communicate pending and adopted legislation and regulations to the appropriate departments and groups in the Company.
- Manage a set of compliance risk metrics derived from an effective mixture of internal sources and self-reporting. Monitor the analysis of compliance metrics to determine appropriate escalations to senior management.
- Determine when and how to recommend the reporting of issues/instances of noncompliance to state, federal, and international regulatory agencies as related to Company activities.
- Establish and maintain processes and procedures to ensure earliest possible detection and remediation of instances of regulatory non-compliance, including proper reporting, documentation, and tracking of deviations or potential deviations as appropriate or required.
- Coordinate and collaborate with Life Sciences management, business delivery and development teams to ensure awareness of regulations and regulatory expectations relevant to Life Sciences lines of business.
- Develop, periodically review and update Life Sciences’ Policies to ensure continuing currency and relevance in providing compliance guidance to management and line personnel.
- Participate as Subject Matter Expert in the creation and delivery of appropriate training and business materials relating to regulatory and compliance.
The Life Sciences Senior Regulatory Compliance Officer will coordinate and support activities for the defined lines of business in scope to achieve, monitor, and maintain operational regulatory compliance to include, but not be limited to the following areas:
- Delivery Process and Methods.
- Lead the Regulatory Compliance team and take responsibility for the following activities:
- Developing Compliance policies and procedures,
- Monitoring and investigating to ensure guidelines and standards are being followed,
- Initiating and managing appropriate operational compliance projects,
- Reporting on status of compliance activities to senior leadership,
- Self-identification (self-reporting and self-audits) and the subsequent implementation of corrective actions,
- Coordinates with other departments to ensure a response occurs related to potential instances of fraud, waste or abuse and the development and implementation of an appropriate corrective or disciplinary action.
- Works with HR and Corporate Compliance to ensure all state and federal exclusion lists have been checked with respect to all associates, officers, directors and managers (if applicable).
- Works with Corporate Compliance to ensure the organization maintains programs that encourage managers and employees to report suspected fraud and other misconduct without fear of retaliation, and to promote a culture of compliance throughout the organization.
- Oversees the development and monitoring of the implementation of corrective and preventative action plans for compliance audits.
- Performs other duties as assigned.
Requirements:
- Bachelor’s Degree; Graduate Degree in related field is highly desirable and preferred.
- One of the following certifications (e.g., SQA, RAC, SCDM, CHC, CCEP, and CIPP/US) is highly desirable.
- Minimum of at least fifteen (15) years of experience in regulatory compliance and/or government regulatory affairs roles as well as experience in a pharmaceutical-related or CRO environment is required, with relevant global, federal and state compliance and operational compliance experience.
- Deep regulatory and procedural knowledge of some or all of the following: cGMP, GCP, GLP, ICH, GVP, 21 CFR Part 11/Annex 11 (EU) and Medical Device regulations and related guidance.
- Understanding of IEEE GAMP guidance for development of systems and software for the pharmaceutical and medical device industries.
- Significant familiarity with HIPAA privacy and security regulations and GDPR as applied to life sciences and clinical research data collected at clinical sites globally
- Highly developed analytical, communication, critical-thinking and problem-solving skills.
- Ability to interpret legislation and regulations, implement policies and procedures effectively
- Interpersonal skills including the ability to listen actively and responsively, delegate responsibilities appropriately and facilitate effective and successful relationships within a matrix management structure
- Effective and persuasive negotiation skills in order to achieve effective regulatory, legal and operational compliance objectives
- Self-starter with the ability to work independently in a fast-paced and flexible corporate environment
- Strong team player with strong collaboration and project/portfolio management skills. Ability to work seamlessly with other members of extremely collegial and supportive business team and organization
- Knowledge of how legislative and regulatory processes work, ability to research laws, regulations as needed.
- Ability and willingness to travel internationally as required by the role.
- Candidate may choose to work fully or partially from their home (with the prior agreement of the line manager).
Application Process – Qualified professionals are to submit their Resume to Elizabeth Parija at: elizabeth@conselium.com
Published by Conselium Executive Search, the global leader in compliance search.
