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 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:
* Collaborate with EMEA affiliates and functions (DACH, Baltics) to manage compliance risks and provide advisory support.
* Act as a compliance expert, guiding departments and local markets to ensure adherence to regulations.
* Review and approve interactions, contracts, and activities (e.g., HCP engagements) within the assigned region.
* Foster a compliance culture by promoting ethical standards, integrity, and accountability.
* Monitor and approve local materials (both promotional and non-promotional).
* Ensure that HCP activities meet legitimate business requirements and fair market value standards.
* Oversee transparency reporting obligations in collaboration with internal and external stakeholders, while managing compliance activities for the DACH and Baltics markets from a Germany-based role
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.