Regulatory Compliance Lead

4 settimane fa

Milano, Lombardia, Italia Merz Therapeutics - Europe A tempo pieno


Regulatory Compliance Lead (m/f/d) Pharma

Regulatory Compliance Lead (m/f/d) Pharma
  • Full Time
  • Location: Italy
  • With Professional Experience

Merz Therapeutics - Europe, a prominent entity in the pharmaceutical sector, is on the lookout for a proficient and proactive Regulatory Compliance Lead (m/f/d). This essential position is integral to our dedication to maintaining excellence in legal, regulatory, compliance, and quality matters, particularly within our Therapeutic division. As a key member of the leadership team, you will report directly to the country managers and collaborate with our headquarters in Germany, as well as various external stakeholders, to ensure adherence to all local and international regulations.

Join us in our mission to deliver "Better outcomes for more patients"

YOUR ROLE

Compliance Oversight:

  • Act as the primary resource for all compliance-related inquiries within Merz Therapeutics - Europe.
  • Guarantee that all operations conform to legal, regulatory, and quality benchmarks.
  • Proactively suggest business-focused compliance strategies.

Risk Assessment:

  • Supervise risk evaluations, audit assessments, and monitoring activities to uphold compliance.
  • Establish suitable risk mitigation and control strategies.

Advisory Role:

  • Offer expert advice, direction, and assistance on compliance matters.
  • Identify deficiencies in existing policies and processes, propose enhancements, and implement necessary adjustments.

External Engagement:

  • Manage relationships with external partners for pharmacovigilance, regulatory affairs, and other compliance domains.
  • Ensure that promotional materials adhere to relevant regulations.

Regulatory Affairs Management:

  • Stay informed about regulatory updates and foresee their implications for the business.
  • Prepare and submit necessary documentation for new product indications and other regulatory approvals.

Pharmacovigilance & Materiovigilance:

  • Collect and report incidents as mandated.
  • Ensure that the team is adequately trained on compliance protocols.

Quality Management & Data Protection:

  • Ensure that Standard Operating Procedures (SOPs) are established, maintained, and adhered to.
  • Develop and modify SOPs as required and train personnel on new processes.
  • Ensure compliance with data protection regulations.

YOUR PROFILE

  • Advanced degree in Law, Pharmacy, Life Sciences, or a related discipline.
  • Extensive experience in compliance, regulatory affairs, or a similar capacity within the pharmaceutical industry.
  • Thorough understanding of Italian and European regulatory frameworks.
  • Current with the latest regulatory developments and their potential business implications.
  • Fluent in Italian and English.
  • Ability to communicate effectively with internal leadership, headquarters in Germany, and external stakeholders.
  • Exceptional attention to detail and precision.
  • Strong problem-solving capabilities with a business-oriented approach.
  • Proactive and solution-focused, consistently proposing feasible compliance solutions.
  • Ability to manage multiple priorities and projects concurrently.
  • Expertise in risk evaluation, audit review, and compliance monitoring.
  • Familiarity with pharmacovigilance, materiovigilance, and data protection regulations.
  • Commitment to ongoing learning and staying updated with industry best practices.

YOUR BENEFITS

  • Permanent employment relationship.
  • High working time flexibility promoting a healthy work-life balance.
  • Attractive working environment with modern, well-equipped facilities.
  • Global family business with flat hierarchies and swift decision-making processes.
  • Collaboration in diverse international teams.
  • Competitive compensation package with comprehensive social benefits.

Why join us? At Merz Therapeutics, you will be part of a global team dedicated to making a significant impact. We provide a collaborative and supportive atmosphere where your contributions are appreciated, and your professional development is encouraged.

For further information about our benefits, please visit our website.

ABOUT US

The Merz Group, a privately held, family-owned enterprise, has been committed to innovation for over 110 years. Merz Therapeutics GmbH is headquartered in Frankfurt am Main, Germany, and operates in more than 90 countries worldwide.

Merz Therapeutics is devoted to enhancing treatment outcomes for patients globally. Through relentless research and development efforts and a culture of innovation, we aim to identify unmet patient needs and provide suitable treatments, particularly for individuals suffering from movement disorders, neurological diseases, liver diseases, and other health challenges that significantly affect quality of life.

For more information, please visit our website.

  • Regulatory Compliance Specialist

    4 settimane fa

    Milano, Lombardia, Italia Jefferies A tempo pieno

    Become a part of our esteemed team at Jefferies GmbHAs a prominent financial institution located in Frankfurt, Germany, we operate as the central hub for continental Europe, with a network of offices throughout the region.Department:Compliance MilanPosition Overview:We are in search of a Regulatory Compliance Specialist to oversee compliance operations at...

  • Regulatory Compliance Specialist

    3 giorni fa

    Milano, Lombardia, Italia Euronext A tempo pieno

    Borsa Italiana - Regulation & Post Trading InternshipJoin Euronext, a leading exchange operator, in a dynamic internship opportunity that will challenge and develop your skills in regulatory compliance and post trading.As a Regulatory Compliance Specialist, you will support the team in ensuring the accuracy and consistency of regulatory provisions, assessing...

  • Compliance Officer

    2 settimane fa

    Milano, Lombardia, Italia Jefferies A tempo pieno

    Job SummaryJefferies GmbH, a leading financial institution, is seeking a highly skilled Compliance Officer to join its team in Milan. As a key member of the Compliance Department, you will be responsible for ensuring the company's compliance with regulatory requirements and industry standards.Key ResponsibilitiesProvide expert advice to front office...

  • Compliance Officer

    2 settimane fa

    Milano, Lombardia, Italia Jefferies A tempo pieno

    Job SummaryJefferies GmbH, a leading financial institution, is seeking a highly skilled Compliance Officer to join its team in Milan. As a key member of the Compliance Department, you will be responsible for ensuring the company's compliance with regulatory requirements and industry standards.Key ResponsibilitiesProvide expert advice to front office...

  • Senior Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia Quidelortho A tempo pieno

    About the RoleWe are seeking a highly skilled Senior Regulatory Compliance Specialist to join our team at QuidelOrtho. As a key member of our regulatory team, you will be responsible for ensuring compliance with local and international regulations, as well as QuidelOrtho standards.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure...

  • Senior Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia Quidelortho A tempo pieno

    About the RoleWe are seeking a highly skilled Senior Regulatory Compliance Specialist to join our team at QuidelOrtho. As a key member of our regulatory team, you will be responsible for ensuring compliance with local and international regulations, as well as QuidelOrtho standards.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure...

  • Regulatory Compliance Auditor

    2 settimane fa

    Milano, Lombardia, Italia IQVIA A tempo pieno

    Job OverviewWe are seeking a highly skilled Clinical Auditor to join our team at IQVIA. As a Clinical Auditor, you will play a critical role in ensuring the compliance of our clients with regulations, guidelines, and operating procedures.Key ResponsibilitiesPlan and conduct independent clinical audits to assess compliance with regulations, guidelines, and...

  • Regulatory Compliance Auditor

    2 settimane fa

    Milano, Lombardia, Italia IQVIA A tempo pieno

    Job OverviewWe are seeking a highly skilled Clinical Auditor to join our team at IQVIA. As a Clinical Auditor, you will play a critical role in ensuring the compliance of our clients with regulations, guidelines, and operating procedures.Key ResponsibilitiesPlan and conduct independent clinical audits to assess compliance with regulations, guidelines, and...

  • Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia Euronext A tempo pieno

    About the RoleThis is an exciting opportunity to join Euronext as a Regulatory Compliance Specialist, supporting the team in ensuring the internal consistency of the provisions of the Rules of Borsa Italiana, MTS, Cassa di Compensazione e Garanzia, and Monte Titoli.Key ResponsibilitiesUpdate, verify, and monitor the internal consistency of the aforementioned...

  • Compliance Officer

    2 settimane fa

    Milano, Lombardia, Italia Jefferies & Company, Inc. A tempo pieno

    Job Description**About Jefferies & Company, Inc.**Jefferies & Company, Inc. is a leading global investment bank and securities firm. Our team is dedicated to providing exceptional service and expertise to our clients.Job SummaryWe are seeking a highly skilled Compliance Officer to join our team in Milan. The successful candidate will be responsible for...

  • Compliance Officer

    2 settimane fa

    Milano, Lombardia, Italia Jefferies & Company, Inc. A tempo pieno

    Job Description**About Jefferies & Company, Inc.**Jefferies & Company, Inc. is a leading global investment bank and securities firm. Our team is dedicated to providing exceptional service and expertise to our clients.Job SummaryWe are seeking a highly skilled Compliance Officer to join our team in Milan. The successful candidate will be responsible for...

  • Senior Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia Ortho Clinical Diagnostics A tempo pieno

    About the OpportunityOrtho Clinical Diagnostics, a world-leading in vitro diagnostics company, is seeking a highly skilled Senior Regulatory Compliance Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring conformity of regulatory processes and strategies to local and international...

  • Senior Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia Ortho Clinical Diagnostics A tempo pieno

    About the OpportunityOrtho Clinical Diagnostics, a world-leading in vitro diagnostics company, is seeking a highly skilled Senior Regulatory Compliance Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring conformity of regulatory processes and strategies to local and international...

  • Senior Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia Ortho Clinical Diagnostics A tempo pieno

    About the RoleWe are seeking a highly skilled Senior Regulatory Compliance Specialist to join our team at Ortho Clinical Diagnostics. As a key member of our regulatory affairs team, you will be responsible for ensuring conformity of regulatory processes and strategies to local and international regulations as well as company standards.Key...

  • Senior Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia Ortho Clinical Diagnostics A tempo pieno

    About the RoleWe are seeking a highly skilled Senior Regulatory Compliance Specialist to join our team at Ortho Clinical Diagnostics. As a key member of our regulatory affairs team, you will be responsible for ensuring conformity of regulatory processes and strategies to local and international regulations as well as company standards.Key...

  • Global Regulatory Compliance Associate

    2 settimane fa

    Milano, Lombardia, Italia Meet Recruitment Limited A tempo pieno

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Meet Recruitment Limited.Key Responsibilities:Assist in the preparation and submission of regulatory documents to regulatory agencies, ensuring compliance with applicable regulations and standards.Prepare submissions of licence variations, notifications, and...

  • Regulatory Compliance Expert in Eyewear

    4 settimane fa

    Milano, Lombardia, Italia Farfetch A tempo pieno

    POSITION OVERVIEW New Guards Group is in search of a committed Regulatory Compliance Expert to enhance our eyewear division. In this role, you will leverage your knowledge to ensure that our eyewear products meet the highest standards of safety, quality, and regulatory compliance for customers globally. KEY RESPONSIBILITIES Interpreting and implementing...

  • Regulatory Compliance Expert in Eyewear

    4 settimane fa

    Milano, Lombardia, Italia Farfetch A tempo pieno

    POSITION SUMMARY New Guards Group is in search of a committed Regulatory Compliance Specialist to enhance our eyewear division. This role is crucial in leveraging your expertise to uphold regulatory standards, ensuring the safety, quality, and compliance of our eyewear offerings for a global clientele. KEY RESPONSIBILITIES Analyzing and implementing...

  • EU Regulatory Lead, Early Phase Oncology

    2 settimane fa

    Milano, Lombardia, Italia Pfizer A tempo pieno

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Global Regulatory Strategic Team, you will be responsible for representing the EU region in regulatory sciences related to our early-stage oncology portfolio.Key ResponsibilitiesDevelop and implement EU regulatory...

  • EU Regulatory Lead, Early Phase Oncology

    2 settimane fa

    Milano, Lombardia, Italia Pfizer A tempo pieno

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Global Regulatory Strategic Team, you will be responsible for representing the EU region in regulatory sciences related to our early-stage oncology portfolio.Key ResponsibilitiesDevelop and implement EU regulatory...