Regulatory Affairs Manager
Posted on :
16-12-2024
Employer Active
1 Vacancy
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Job Description
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As a CMC Regulatory Affairs Manager, you will manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle including keeping business wide electronic systems up to date to maintain regulatory status.
Duties:
- Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including clinical programs, marketing authorisation applications and all post approval approval activities
- Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.
- Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
- Documenting maintenance and communication of Health Authority approval status
- Provides expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
- Project management expertise with the ability to adapt to changing situations to ensure on time delivery.
- Proactively share learning from own projects with other colleagues
- Where applicable, act as Subject Matter Expert (SME) contributing to and advising project teams.
- Supporting the agreed strategy to employ fit for purpose content applying regulatory intelligence and to optimise proposed submission content
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Minimum Requirements:
- Degree in Chemistry, Pharmacy or Chemical Engineering, or equivalent experience
- Fluently spoken and written English
- Experience in CMC Regulatory Affairs within pharma industry of at least 5+ years
- Experience in Post approval variations and MAAs is key
Employment Type
Full-time
Key Skills
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