Role: Project Manager CMC Regulatory
Location: New Jersey
Duration: 12+ Months
Interview Mode: Webx
CMC 3 - At least seven (7) years of relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical Device/instruments; or related fields.
Comfortable working independently
24-48 hours timeline for resume review
3 round interviews, round 1 phone, round 2 client phone interview, round 3 client in person interview
Description of Role and Responsibilities "Essential function(s) includes, but is not limited to:
Reporting to the Director, the Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical device/instruments in accordance with global regulations and guidance’s, and Merck procedures. The Associate Director will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial devices. The Associate Director may manage a team of 2 to 4 individual contributors in support of project execution.
• Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the device/instrument 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 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"
• 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. "
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