Pharmaceutical Regulatory and Compliance Legal
Vor 6 Tagen
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.
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.
Axiom Global (Deutschland) GmbH, Messeturm, 22. Etage, Friedrich-Ebert-Anlage 49, 60308 Frankfurt am Main. Amtsgericht: Frankfurt am Main. HRB 104281. Geschäftsführer: Daniel Hayter
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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