Our client is a global leader in business and technology services and our Budapest centre provides near-shore IT Development, IT Infrastructure Services and BPO support for several of our global customers that include the world leaders in Pharma, Banking, Consumer Goods, Insurance and Telecom.
Currently they are looking for talented people for the roles of:

 

Regulatory Compliance Officer (Life Sciences)

 


Scope of position:

● Life Sciences business domains: lines of business include (but shall not be limited to) CRO and CRO component services, and Life Sciences' Software Products and Platforms, Business Process Outsourcing (BPO) and Business Process as a Service (BPaaS)
● Laws and Regulations (including but not limited to): EU, UK, US, India, Japan and others regulatory requirements’ for GxPs, computerized systems (21 CFR Part 11/Annex 11), and data privacy spanning pharmaceuticals, biotechnology, vaccines, and medical device industries

 

Responsibilities:

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 the 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

 

Reporting structure:

The Life Sciences (Associate) Regulatory Compliance Officer will report to the Life Sciences Business Unit Compliance Officer.

 

Requirements:

● Bachelor’s Degree in political science, law, business, scientific, computer science or related field is required
● One of the following certifications (e.g., SQA, RAC, SCDM, CHC, CCEP, or CIPP/US) is highly desirable
● Minimum 10 years of experience in ethics & compliance, regulatory compliance or few years spent in government regulatory affairs roles
● Strong pharmaceutical/ biotechnology/ life science background
● Quality Assurance experience needed
● 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:

● Opportunity to be part of a rapidly expanding organization
● A role that provides you progress both professionally and personally
● Pleasant and inspiring working atmosphere with multicultural community and state-of-the-art technologies


Place of work: Budapest / Hungary

 

 

 

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