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 youll 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 :
- Bachelors 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.
Remote Work :
No
Employment Type :
Full-time
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 ...
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 youll 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 :
- Bachelors 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.
Remote Work :
No
Employment Type :
Full-time
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