Merz Pharma Italia, a leading player in the pharmaceutical industry, is seeking a highly skilled and dynamic Compliance Manager (m/f/d). This pivotal role is central to our commitment to excellence in legal, regulatory, compliance, and quality matters, supporting our Therapeutic business. As a member of the leadership team, you will report directly to the country managers and liaise with our headquarters in Germany and various external parties to ensure compliance with all local and international regulations.
Be part of our growth and bring “Better outcomes for more patients”
YOUR CONTRIBUTION
Compliance Leadership:
- Serve as the primary point of reference for all compliance-related matters within Merz Pharma Italia.
- Ensure that all activities align with legal, regulatory, and quality standards.
- Proactively propose business-oriented compliance solutions.
Risk Management:
- Oversee risk assessment, audit reviews, and monitoring to maintain compliance.
- Implement appropriate risk mitigation and control measures.
Advisory and Support:
- Provide expert advice, guidance, and support on compliance issues.
- Identify gaps in current policies and processes, recommend improvements, and implement necessary changes.
External Relations:
- Manage relationships with external support for pharmacovigilance, regulatory affairs, and other compliance areas.
- Ensure promotional materials comply with Italian and CE mark regulations.
Regulatory Affairs:
- Stay abreast of regulatory changes and anticipate their impact on the business.
- Prepare and submit materials required for new product indications and other regulatory approvals.
Pharmacovigilance & Materiovigilance:
- Collect and report incidents as required.
- Ensure the team is properly trained on compliance procedures.
Quality Management & Data Privacy:
- Ensure Standard Operating Procedures (SOPs) are established, maintained, and followed.
- Develop and adapt SOPs as needed and train staff on new procedures.
- Ensure compliance with data privacy regulations.
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