Compliance Manager Italy (m/f/d) Pharma

Merz Therapeutics; Milano; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Milan is seeking a highly skilled Compliance Manager. This pivotal role involves ensuring compliance with legal and regulatory standards, overseeing risk management, and providing expert advisory support. The ideal candidate will have extensive experience in compliance within the pharmaceutical industry, knowledge of regulatory affairs, and be fluent in both Italian and English. This role offers high flexibility and attractive compensation.

Servizi

High working time flexibility

Attractive location in central Milan

Collaboration in international teams

Comprehensive social benefits

Competenze

• Extensive experience in compliance, regulatory affairs, or similar roles in pharma.
• In-depth understanding of Italian and European regulatory requirements.
• Fluent in Italian and English.

Mansioni

• Serve as the primary point of reference for compliance-related matters.
• Oversee risk assessment and implement mitigation measures.
• Manage relationships with external compliance partners.

Conoscenze

Compliance expertise

Risk management

Regulatory knowledge

Problem-solving

Formazione

Advanced degree in Law, Pharmacy, Life Sciences

Descrizione del lavoro

Overview

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 Italian and English language skills
• 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.

About us: Merz Group is a privately held, family-owned company with over 110 years of innovation. Merz Therapeutics GmbH is headquartered in Frankfurt am Main, Germany, and represented in more than 90 countries worldwide including Italy. Merz Therapeutics focuses on patients with movement disorders, neurological diseases, liver diseases, and other conditions affecting quality of life.

For more information, Merz Therapeutics information is available internally.

Merz Pharma Italia, S.L., Via F. Filzi, 25/A, 20124 Milano