• , US

Company:  Confidential

Job Title: Regulatory Operations Dir.

Job Number: 74043

Location: , US

Job Description

Looking to hire a Director, Regulatory Operations to a growing team team, reporting to the Chief Regulatory Officer. Responsibilities include managing regulatory submissions and implementing procedures for submission activities, including electronic submissions and document management. You’ll schedule submission timelines, track project deliverables, and ensure timely completion. Knowledge of submission requirements for US and international regulatory authorities is necessary.

Responsibilities

* Plan and track project timelines to meet company goals. * Oversee global publishing and submissions for regulatory authorities. * Coordinate with vendors for document management. * Validate electronic regulatory systems for compliance. Optimize systems for efficiency. * Manage and mentor regulatory operations staff. * Collaborate with vendors to streamline application processes. * Cultivate relationships with business partners. * Manage multiple tasks in a fast-paced environment. * Fulfill additional duties as needed.

Required Skills

* BA/BS degree or equivalent; advanced degree preferred. * 7-10 years Regulatory Operations experience, 6+ in biotech/pharmaceutical. * Supervisory and mentoring experience. * Proficient in managing staff and vendors. * Strong project management skills. * Extensive use of document management systems. * Strong communication skills.

Application Deadline: 2024-03-18

 

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