CMC Regulatory Affairs Specialist
Posted on :
04-11-2022
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Job Description
Responsibilities:
- 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 MMD 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 GRACS CMC management, as needed"
- Bachelor's Degree or international equivalent required; Life Sciences preferred.
- Minimum 3-5 years of experience in Global Regulatory Affairs, preferably with a global manufacturer of medical devices.
- Strong experience in CMC requirements for small molecule/biologic products.
- Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
- Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal and negotiating skills.
- Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Employment Type
Full Time
Key Skills
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