- Responsible for leading Regeneron's compliance-related activities in the DACH region, and other European markets as needed
- Drive the implementation and management of Regeneron's DACH compliance programs and policies in coordination with the Headquarter (HQ)-based compliance team and the Law Department representatives in HQ and other markets
- Support the development and implementation of compliance policies, working process documents, and relevant compliance guidance that integrate appropriate healthcare, corporate, and other compliance controls to guide DACH and other European operations as needed
- Assist and support the further refinement, implementation, and execution of a Compliance training program for new and existing employees and relevant third parties to ensure a thorough understanding and appreciation of the laws and industry codes of practice that impact the company's operations and how to conduct business practices appropriately
- Provide compliance/risk management support for the company's expanding operations, proactively working with business leaders to identify compliance risks and issues, and collaborate cross-functionally to offer creative solutions to mitigate risks
- Provide timely guidance and compliance oversight on existing and novel initiatives, which include interactions with HCP and HCOs. For example, confirming the Regeneron planned HCP events are executed consistent with Regeneron policies and procedures
- Identify emerging industry and company trends to mitigate compliance risks through proactive risk management
- Collaborate with the Compliance Monitoring team to conduct periodic internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended, business activities in-line with local industry codes (e.g., FSA) and that the company identifies potential compliance risks and remediates where necessary
- Thorough functional in-depth knowledge and understanding of the (bio-)pharmaceutical industry and its business operations with expertise in the body of laws, regulations, guidance, and codes of practice impacting pharmaceutical companies, including knowledge of compliance issues related to the development and commercialization of branded pharmaceutical products
- Deep understanding of the self-regulatory framework for the pharmaceutical industry across Europe with a strong working knowledge of the DACH country codes (e.g. FSA code) and understanding of the overarching principles of EFPIA & IFPMA
- Ability to effectively interact with and advise Executive/Sr Level Leadership including Country Leadership
- Strong problem-solving, decision-making, interpersonal and communication skills with demonstrated ability to think creatively and devise solutions to challenging problems
- Ability and willingness to travel
- You have a deep understanding of European and other ex-US healthcare compliance laws, regulations, and industry codes of practice governing biopharmaceutical industry business practice including but not limited to commercial, medical affairs, market access, and, clinical development activities
- A minimum of 5-7 years working in or with (bio-)pharmaceutical companies on healthcare compliance related activities
- Extensive experience and skill at writing and deploying policies and guidance documents supporting various business activities
- Exceptional influencing and interpersonal skills and the ability to drive change
- Fluency in German and English languages is required, any other European language is a plus
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Director Compliance DACH - Munich, Deutschland - Regeneron
Beschreibung
At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we're establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health.
To further our mission, we are seeking a
Director Compliance DACH (f/m/d)
based in Munich (Germany) - hybrid work arrangement acceptable subject to Company guidance.
You will be a key member of the Global Corporate Compliance Operations team reporting into the Senior Director Compliance, charged with supporting business operations and delivering on a variety of compliance-related activities for Regeneron in Germany, Switzerland, Austria (DACH), and other European markets as needed. You will be involved in the development and implementation of policies that form Regeneron's compliance program, assisting with internal investigations, supporting local monitoring efforts, advising the Compliance Policy Lead, conducting training and serving as a local subject matter expert on industry codes of practice (i.e., FSA) and appropriate country specific ways of conducting business. The position will work closely with compliance leads from Monitoring, Internal Investigations, Compliance policy, training, communications, and Global Transparency and this role will sit on the various Country leadership teams, as well as work with other members of the Law Department, in their efforts supporting the Regeneron global enterprise.
Responsibilities
Requirements
Qualifications
Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines, and our culture of ownership and enablement. And join us, as we build a future we believe in.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
