Senior Regulatory Affairs Manager
Indivior
full-time
Posted on:
Location Type: Remote
Location: France
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Job Level
About the role
- Suggest and implement the technical and regulatory strategy for operations concerning registration, manufacture and sale of Indivior’s products.
- Perform all activities related to registration and maintenance of marketing authorizations (MA).
- Ensure compliance with regulations for France and Germany regarding regulatory affairs, quality assurance, and pharmacovigilance activities.
- Liaise with health authorities to lead regulatory strategies for product portfolio.
- Monitor and interpret local regulatory issues that impact products.
Requirements
- Advanced degree in Pharmacy
- A minimum of 10 years' experience in Regulatory Affairs is required.
- Working knowledge of key health authorities in EU.
- Experience in narcotic pharmaceutical business is preferred.
Benefits
- Passion. Innovation. Achievement. All are key aspects of a career with Indivior.
- We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient.
- The Indivior leadership team has built a global organization of individuals connected by a thriving culture.
- Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategymarketing authorizationsquality assurancepharmacovigilancecomplianceregistrationmanufacturenarcotic pharmaceuticals
Certifications
advanced degree in Pharmacy