Regulatory Compliance Officer - Life Sciences (PE-9814)
The Life Sciences (Associate) Regulatory Compliance Officer will coordinate and support activities to achieve, monitor, and maintain operational regulatory compliance in the following, but not limited to, areas:
• Develops, implements and manages regulatory compliance program as required for some or all of Life Sciences CRO and CRO 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.
• Provides thorough regulatory compliance oversight, internal advisory/consulting and monitoring/reporting activities to ensure compliance with all applicable global regulations.
• Coordinates and collaborates with Life Sciences management, business delivery and development teams to ensure awareness of regulations and regulatory expectations relevant to Life Sciences lines of business.
• Conducts periodic compliance reviews the Company’s Life Sciences operations for adherence to policies and procedures.
• Ensure earliest possible detection and remediation of instances of regulatory non-compliance, including proper reporting, documentation, and tracking of deviations.
• Works with executive and senior management on strategic and operational planning activities to ensure compliance with all applicable regulations.
• Interfaces with compliance professionals (e.g., privacy, security, legal) across Company domains to ensure that Life Sciences lines of business are aligned with corporate expectations.
• Assesses regulatory risk across all Life Sciences lines of business and ensures effective risk mitigation.
• Interprets and communicates pending and adopted legislation and regulations to the appropriate departments and groups in the Company.
• Ensures that Life Sciences implements new laws and regulations that impact regulated activities and products.
• Manages, analyses, and monitors a set of compliance risk metrics to determine appropriate escalations to senior management.
• Oversees the development and monitoring of corrective and preventative action plans from compliance investigations.
• Determines when and how to recommend the reporting of issues/instances of noncompliance to state, federal, and international regulatory agencies as related to Company activities.
• Participate as Subject Matter Expert in the creation and delivery of appropriate training and business materials relating to regulatory and compliance.
• Develop Compliance policies and procedures.
• Leads or participates in directed investigations as assigned. Ensures discretion when dealing with potentially sensitive matters. Prepares and maintains confidential investigation documentation.
• 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.
• Performs other duties as assigned.
• Bachelor’s Degree in political science, law, business, scientific, computer science or related field is required; Graduate Degree in political science, law (J.D.), business or scientific field is highly desirable and preferred.
• One of the following certifications (e.g., SQA, RAC, SCDM, CHC, CCEP, or CIPP/US) is highly desirable.
• Minimum of at least 10 years of experience in ethics & compliance, regulatory compliance, and/or government regulatory affairs roles as well as experience in a pharmaceutical-related or CRO environment is required.
Qualifications, Knowledge, Skills & Abilities:
• Deep, global regulatory and procedural knowledge of some or all of the following: cGMP, GCP, GLP, ICH, 21 CFR Part 11, and Annex 11.
• Detailed understanding of the pharmaceutical, biotechnology, vaccines, and/or medical device industries.
• 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.
• Ability to be a motivator with visionary ability and capacity to implement new ideas in a positive and supportive manner.
• 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.
• Self-starter with the ability to work independently in a fast-paced, virtual/remote 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 to collaborate with Corporate Compliance, Regulatory Legal, Privacy, Information Security, Commercial Legal, and Corporate Legal, when appropriate (e.g., adverse situations needing interpretation or potential issue escalation).
• Experienced and skilled in management within a cross-functional, cross-cultural organisation and in a client/service provider business setting.
• Ability and willingness to travel internationally as required by the role.
WHAT WE OFFER:
• Use and improve your language knowledge
• Multinational environment
• Excellent salary and benefits package
• Development opportunities