Junto HLS is working exclusively with Regulatory Leadership at a top healthcare company in Northern New Jersey to recruit a Regulatory CMC Team Leader to oversee North American Regulatory Affairs CMC. The incumbent will lead RA CMC work across a multitude of market leading products/projects, many of which you’d be familiar with as both a professional and a consumer.
- Manage CMC Regulatory team and ensure all project milestones are met and CMC support for marketed products is provided in accordance with established deadlines;
- Deliver all CMC Regulatory milestones for assigned products across the product lifecycle;
- Identify, communicate and escalate potential CMC Regulatory issues to Regulatory Management and communicate mitigation strategies;
- Provide CMC Regulatory leadership as needed to product in-license/due diligence review, product divestment;
- 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;
- Execute CMC Regulatory strategies by review of CMC submission components and documentation to support post-approval supplements, annual reports, and registration and responses to FDA questions per established business processes and systems;
- Collaborate with R&D and other cross-functional partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance;
- Represent company in technical Trade Associations;
- Gather and analyze technical Regulatory information and lead the implementation into company procedures;
- Assist CMC Regulatory team members with career development and yearly business and development objectives. Conduct meaningful reviews with team members to ensure alignment with departmental objectives and personal development goals.
- Northern, NJ
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.