Manager of Post Market Compliance overseeing post - market surveillance for global medical device regulations. Engaging with cross - functional teams and maintaining compliance standards in a hybrid role.
About the role
- Senior Regulatory Consultant providing strategic regulatory support to pharmaceutical companies. Collaborating on regulatory activities across the EU and US, ensuring compliance and successful submissions.
Responsibilities
- Advising on regulatory development strategies and approval pathways
- Coordinating regulatory activities in EU and US development programmes
- Supporting procedures such as Scientific Advice, PIP and orphan designation
- Contributing to or leading marketing authorisation applications (MAA/NDA)
- Preparing and coordinating regulatory documentation, submissions & publishing, including eCTD and IRIS
- Managing variations and other post-approval regulatory activities
Requirements
- A degree in pharmacy or another relevant life science discipline
- Several years of experience in regulatory affairs for pharmaceuticals
- Experience from industry, a regulatory authority or consulting
- Experience with regulatory submissions or regulatory project coordination
- Excellent communication skills in English and Swedish
Benefits
- Flexibility to work from home or the office,
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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