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. YOUR PROFILE
Advanced degree in Law, Pharmacy, Life Sciences, or a related field Extensive experience in compliance, regulatory affairs, or a similar role within the pharmaceutical industry In-depth understanding of Italian and European regulatory requirements Up-to-date with the latest regulatory changes and their potential business impacts Fluent in Italian and English Ability to liaise effectively with internal leadership, HQ in Germany, and external parties Exceptional attention to detail and accuracy Excellent problem-solving skills with a business-oriented mindset Proactive and solution-oriented, always proposing viable compliance solutions Ability to manage multiple priorities and projects simultaneously Expertise in risk assessment, audit review, and compliance monitoring Familiarity with pharmacovigilance, materiovigilance, and data privacy regulations Commitment to continuous learning and staying current with industry best practices YOUR BENEFITS
Permanent employment relationship High working time flexibility which enables a good work-life balance Attractive location in central Milan with good transport links and modern, well-equipped workplaces Global family business with flat hierarchies and short decision processes Collaboration in multi-functional international teams Attractive compensation with comprehensive social benefits Why join us? At Merz Therapeutics, you'll be part of a global team committed to making a difference. We offer a collaborative and supportive environment where your contributions are valued, and your professional growth is nurtured.
You can find more information about our benefits here.
ABOUT US
The Merz Group, a privately held, family-owned company, has been dedicated to the development of innovations for more than 110 years. Merz Therapeutics GmbH is headquartered in Frankfurt am Main, Germany, and is represented in more than 90 countries worldwide including Italy.
Merz Therapeutics is committed to improving treatment outcomes for patients around the world. With our relentless research & development efforts and culture of innovation, we strive to identify unmet patient needs and provide appropriate treatments. In particular, we focus on patients suffering from movement disorders, neurological diseases, liver diseases and other health issues that severely impact quality of life.
For more information visit our website: Innovazioni terapeutiche per i nostri pazienti | Merz Therapeutics
Merz Pharma Italia, S.L. , Via F.Filzi, 25/A, 20124 Milano
Sarah Meißner HR Business Partner
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