Compliance Business Partners are essential for ensuring that local affiliate operations comply with the complex and stringent regulations of the pharmaceutical industry. These professionals ensure adherence to local, national, and international laws (e.g., marketing/medical practices, transparency laws, ABAC, HCP interactions) and mitigate risks associated with non-compliance, such as fines, legal liabilities, and reputational damage. They implement internal policies and training programs to foster an ethical culture and continuous improvement, protecting public health and corporate integrity.
The Compliance Business Partner Manager acts as the "face of Compliance," serving as the main point of contact for the business in a specific region (DACH and Baltics) and collaborating with key stakeholders across the EMEA organization. This role requires deep knowledge of compliance principles in the pharmaceutical industry and the ability to provide strategic guidance and support.
This position is responsible for oversight of Compliance activities in DACH and Baltics. This position will sit in Germany.
What you'll do:
Act as Compliance Business Partner to EMEA affiliates and functions (DACH, Baltics)
Direct and coordinate front-line compliance engagement and risk management advisory support to the business
Serve as a subject matter expert on compliance, providing guidance across departments in line with applicable laws, regulations, and company standards
Advise on compliance risks, potential issues, and mitigation strategies
Review and approve interactions, engagements, and contracts (e.g. HCP engagements) across the region in accordance with legal, regulatory, and Santen requirements
Foster and promote a strong culture of compliance, ethics, integrity, and accountability, including awareness and training initiatives
Collaborate with departments to educate and support local markets in acting compliantly
Work closely with the Compliance team, leveraging standards, tools, and templates and providing feedback for continuous improvement
Perform documentation and onsite monitoring activities
Act as Compliance Approver for local promotional and non-promotional materials in line with legal, industry, and Santen standards
Review and approve HCP engagements for local contracted activities, ensuring legitimate business need and Fair Market Value documentation
Approve Medical Affairs HCP engagements
Oversee transparency reporting obligations with internal and external stakeholders
Support EMEA Compliance with regional and global initiatives, projects, and execution of the annual EMEA Compliance plan
Follow GDP guidelines and act in line with them (mandatory for all employees)
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 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.
- Professional fluency in English and German.
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.
About the Company
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.
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