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
The Compliance Business Partner Manager plays a crucial role in overseeing compliance operations in local affiliate markets, ensuring adherence to complex regulations in the pharmaceutical industry. Their responsibilities include maintaining compliance with local, national, and international laws related to marketing, medical practices, transparency, ABAC, and HCP interactions. They mitigate risks such as fines, legal liabilities, and reputational damage by implementing internal policies and training programs that promote ethical conduct and continuous improvement.
This role requires expertise in compliance principles and the ability to provide strategic guidance to stakeholders. Specifically, the Compliance Business Partner Manager will oversee compliance activities in Italy and Iberia, ensuring adherence to stringent transparency requirements for transfers of value (TOVs) with healthcare professionals (HCPs).
What you'll do:
- Provide front-line compliance risk management advisory support to the business.
- Act as a subject matter expert on compliance matters, offering guidance across the regional cluster.
- Advise on compliance risks, potential issues, and mitigation strategies.
- Review and approve interactions, engagements, and contracts, including HCP engagements, across the region.
- Foster a culture of compliance by promoting ethical behavior, integrity, and accountability through awareness initiatives.
- Collaborate with the Compliance Champion Network to educate and support local markets in maintaining compliance.
- Leverage and provide feedback on compliance standards, tools, and templates to improve processes.
- Oversee compliance activities for EMEA affiliates, focusing on Italy and Iberia, including live monitoring and HCP engagement approvals.
Qualifications
What you'll bring to the role:
- Fluency in both Italian and English languages, Spanish is strongly preferred.
- 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.
- Experienced in developing and implementing compliance programs, with strong analytical, problem-solving, communication, and interpersonal skills to assess complex situations and collaborate effectively with stakeholders at all levels.
- 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.
