Regulatory Affairs Director jobs in Nassau, NY

The Manager CMC Regulatory Affairs is responsible for interpreting the current, approved and planned clinical regulatory landscape by contributing to the management of the regulatory submission form process

Essential Duties and Responsibilities include, but are not limited to, the following:

• Contributes to the management of the regulatory submission form process, which involves the review of submitted documentation to global health authorities to support the release of lots to clinical trials.

• Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs.

• Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials. Ensure appropriate communication between IOPS and global development in a timely manner.

• Participates in the development of procedures and systems for enhanced tracking of global regulatory submission packages and approval status.

• Lead meetings and presentation on more complex regulatory issues and participates in creating regulatory justifications.

• Keeps management and all stakeholders informed of assessments, overall strategy, and project status.

• Contribute to training programs, metrics, and invoice approvals.

• May act as a submission compliance liaison with other areas of Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure the submissions appropriately support the release of IP.

Education and Experience:

• Requires BS/BA in Chemistry, Biology or related field (advanced degree preferred).

• 5 years of experience working in the biopharmaceutical manufacturing or related industry including experience working in regulatory or compliance related activities.

• Minimum 2 years of leadership and/or managerial experience required.

Knowledge and Skills:

• Ability to build collaboration and teamwork across cross functional teams.

• Working in an ambiguous environment and able to produce maximum results with minimum direction and guidance.

• Demonstrated history of building and maintaining positive relationships both internally and externally.

• Strong communication and negotiation skills

• Open and receptive to change while continually looking for opportunities to improve processes.

• Strong understanding of quality principles in a regulated manufacturing environment would be helpful.