Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
About the role
- Regulatory Responsible leading CMC activities at Opella, ensuring compliance and supporting Marketing Authorizations. Involves documentation, change control, and collaboration with regulatory affairs.
Responsibilities
- Manage CMC documentation: Write, update, and review regulatory CMC dossiers for submission; coordinate internal and external CMC writing; optimize dossier content for future changes; prepare responses to Health Authority queries.
- Support Marketing Authorizations worldwide: Handle territory extensions, renewals, site registrations, and transfers by preparing CMC documents and collecting GMP-related documentation.
- Change Control: Assess regulatory impact of product lifecycle changes; define regulatory strategies; track submissions and approvals of variations globally.
- Ensure Regulatory Compliance: Align CMC dossiers with manufacturing and control procedures; evaluate compliance against current regulations; define corrective actions for gaps.
- Act as the regulatory interface with Global and Affiliate Regulatory Affairs for EM CHC.
- Support business units in managing new opportunities and product launches.
Requirements
- Hands-on experience in CMC writing and/or Regulatory Affairs.
- Background in pharmaceutical industry within GMP environments (Quality Assurance, Development, Production, or Quality Control).
- Strong written and verbal communication skills; ability to collaborate across functions.
- Excellent organizational skills with attention to detail and ability to manage multiple priorities.
- Knowledge of global drug regulations (EU, FDA, ICH, China).
- Familiarity with Veeva Vault RIM and Veeva Vault Quality is a plus.
- Proficient in English (written and spoken); additional languages are a plus.
Benefits
- Health insurance
- Competitive salary
- Professional development opportunities
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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