MSI Pharma are looking to hire a CMC Regulatory Affairs Specialist for a US based pharmaceutical firm. This is a contract role and can be worked fully remotely from anywhere in the USA.
In this role you will:
- Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product life-cycle
- Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes
- Plan the project by understanding the client needs, managing project deliverables and providing solutions in real time
- Collaborate with client and external partners to support compliant execution of change management
- Manage execution / authoring of CMC documentation (Module 1 , 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
- Deliver all regulatory milestones for assigned products across the product lifecycle, deliver on agreed SLAs with clients at contract and account/ project level. Meet all monthly reporting/business metrics/KPIs requirements and manage internal control processes
- Identify, communicate and escalate potential regulatory issues / risks and propose mitigation
- Ensure established policies and procedures of the organization/client are followed and ensure compliance
You must have:
- Experience in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports
- Experience in authoring of assessment reports and Part2/ Expert reports for Dossiers
- Experience in reviewing of quality documents such as assay methods (anti-oxidant assay, anti-microbial agent assay), process validations, particle size method implementation and specification etc.
- Fluent English oral and written communication skills
- Bachelor's or master's degree required in science, engineering or related field (advanced degree preferred)
- 6-10 years experience in the Pharmaceutical Regulatory Industry/ CMC
- Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields
- Marketing authorization experience
- Proven Project Management experience
If you are interested then please apply now! If you would like more information then email us or call 0333 307 6873. We look forward to your application.