Compliance Business Partner (Italy & Iberia)

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 

Job Description

Compliance Business Partners are essential for overseeing our compliance operations in the local affiliate markets to ensure adherence to complex and stringent regulations governing our industry. These professionals are responsible for maintaining compliance with local, national, and international laws, including those related to marketing/medical practices, transparency laws, ABAC, HCP interactions and more. They help mitigate risks associated with non-compliance, such as hefty fines, legal liabilities, and reputational damage. Additionally, compliance professionals implement and monitor internal policies and training programs to foster a culture of ethical conduct and continuous improvement, ensuring that the company’s operations align with industry best practices and regulations. Their expertise and vigilance are critical in navigating the ever-evolving regulatory landscape, thereby protecting public health and the company’s integrity.

The Compliance Business Partner Manager will serve as the “face of Compliance”, working with the business in a given cluster, liaising with key stakeholders across the EMEA organization.

The Compliance Business Partner, Manager, plays a critical role in ensuring that Santen adheres to all applicable laws, regulations, and industry standards. This position requires a deep understanding of compliance principles within the pharmaceutical industry, as well as the ability to provide strategic guidance and support to various stakeholders.

This position is responsible for oversight of Compliance activities in Italy and Iberia. This role will ensure that we meet the stringent Italian requirements of transparency on all TOVs wit HCPs. This position will sit in Italy

• Focused on directing and coordinating front-line engagement and compliance risk management advisory support to the business.
• Serve as a subject matter expert on compliance matters, providing guidance and support to various departments within the specified region cluster.
• Advise on compliance risks, potential issues, and mitigation strategies.
• Conduct review and approval of various interactions, engagements and contracts (e.g., HCP Engagements) across region cluster.
• Foster a culture of compliance. Promote a strong culture of compliance throughout the organization. Encourage ethical behavior, integrity, and accountability among employees. Implement initiatives to raise awareness and reinforce compliance standards.
• Collaborate with network of Compliance Champions to educate and support local markets to act compliantly.
• Collaborate with the Compliance team by leveraging their standards, tools and templates to support the business while relaying feedback to help in the development of those standards, tools, and templates
• Compliance Business Partners to EMEA Affiliates and Functions (Italy and Iberia)
• live onsite monitoring
• HCP engagements and contracts
• Oversight and coordination of Compliance Champion Network (where needed)
• Approver of Medical Affairs HCP engagements approvals

Qualifications

• Bachelor’s degree in a relevant field (e.g., Law, Business, Life Sciences). Advanced degree preferred.
• Minimum of 5-7 years of experience in compliance, preferably within the pharmaceutical industry.
• In-depth knowledge of European pharmaceutical regulations, including but not limited to EFPIA, IFPMA
• Strong understanding of European and international compliance standards and guidelines.
• Proven experience in Compliance in Italy and Spain
• Fluent in Italian and English. Spanish is a plus.
• Proven experience in developing and implementing compliance programs and strategies.
• Excellent analytical and problem-solving skills, with the ability to assess complex situations and provide practical solutions.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
• Ability to work independently, manage multiple priorities, and meet deadlines
• Professional certifications in compliance (e.g., Certified Compliance and Ethics
• Professional, Certified Regulatory Compliance Manager) are a plus

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator – addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

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