Manager

Discover the role:

Contribute to the management of the regulatory submission form process, which involves reviewing documentation submitted 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, ensuring timely communication between IOPS and global development.

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

Lead meetings and presentations on more complex regulatory issues and participate in creating regulatory justifications. Keep management and all stakeholders informed of assessments, overall strategy, and project status.

Contribute to training programs, metrics, and invoice approvals.

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

This role requires:

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

Minimum of 8 - 10 years of experience working in the biopharmaceutical manufacturing or related industry, including experience in regulatory or compliance related activities.

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

Strong compliance background preferred.

Experience in program management is a plus.

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

Ability to work in an ambiguous environment and 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 is helpful.