I am currently looking for a CMC – regulatory affairs consultant based in / around New Jersey.
This is a full time contract role with a competitive rate.
* 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 lifecycle.
* Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
* Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
* Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
* Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
* Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
* Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
* Assess and communicate potential regulatory risks and propose mitigation strategies.
* Deliver all regulatory milestones for assigned products across the product lifecycle
* Identify, communicate and escalate potential regulatory issues to CMC management, as needed
If this sounds like a good fit for you apply below!
