Pharmaceutical Regulatory And Compliance Legal Counsel

We are currently seeking a Pharmaceutical Regulatory and Compliance Legal Counsel (m/f/d) to work with a our client, a F100 technology company] in-house.
This is an exciting opportunity where you can bring your legal background and business acumen to work on cutting-edge while tackling complex legal challenges on a global scale. This opportunity enables you to leverage your experience and expertise to counsel and collaborate with some of the most innovative and dynamic minds in the industry while developing a diverse set of skills.
Responsibilities

• • Ensure compliance with German and EU pharmaceutical regulations, focusing on pharmacovigilance and medical affairs. Must have successfully passed the 2nd State Exam in Germany.
  • Provide regulatory guidance across departments, emphasizing strategic compliance in pharmacovigilance and medical affairs, to support product lifecycle management.
  • Lead submission of regulatory documents, including MAAs and pharmacovigilance reports, maintaining product registrations with German authorities.
  • Act as the main regulatory contact in Germany, ensuring adherence to pharmacovigilance and medical affairs standards.
  • Update and train internal teams on regulatory changes, leveraging expertise in pharmacovigilance and medical affairs. Open to remote work within Germany, emphasizing flexibility.
    

Minimum Qualifications

• 5+ years of relevant experience.
• Sense of urgency combined with strong interpersonal skills and an ability to work both independently and cross functionally.
• 1st and 2nd German state exams; additional degree or specialization is a must.
• Fluent English required; additional European languages advantageous.
  

Compensation, Benefits & Location:
This role offers a highly competitive compensation and benefits package in the alternative legal services marketplace, that includes health benefits, Pension and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely, with the exception that some clients require on-site presence.
Axiom is the global leader in high-calibre, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today’s business landscape with best in breed alterative legal services.
Axiom is a leader in diversity, inclusion, and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ+ Equality, earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axiom’s legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation.
Learn more about working at Axiom.
Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender reassignment, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment.
Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form, please contact us at benefits@axiomlaw.com and include “Applicant Accommodation” in the subject line.
Axiom Global (Deutschland) GmbH, Messeturm, 22. Etage, Friedrich-Ebert-Anlage 49, 60308 Frankfurt am Main. Amtsgericht: Frankfurt am Main. HRB 104281. Geschäftsführer: Daniel Hayter
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Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work.
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