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Regulatory Operations Manager

REMOTE, KS 00000

Posted: 09/11/2022 Employment Type: Direct Hire/Perm Job Category: Regulatory Sciences and Medical Writing Job Number: 505253 Country: United States Is job remote?: Yes

Job Description

Job Description

The Regulatory Operations Manager is responsible for Group regulatory submission standards and current electronic submission guidelines/requirements. The Regulatory Operations Manager will also be responsible for managing day-to-day submission-related tasks, managing projects and/or personnel, and mentoring junior Regulatory operations staff.

Essential Functions Include:

Provide input/recommendation to Regulatory Affairs, Program Management, and Medical Writing Teams on electronic submissions strategies to support IND, CTA, NDA, BLA, MAA, etc. applications.
Manage publishing activities including ensuring documents are submission ready, preparation and transfer of final documents, troubleshooting and supporting client(s) and internal team during submission preparation, managing, and completing QC of output, and confirming submission to the health authority.
Track regulatory commitments and deliverables to health authorities.
Assist with the development and implementation of standard procedures for publishing, archiving, metrics, and submission process to global health authorities.
Assist with developing, revising and maintaining of best practices for Regulatory Operations department to ensure compliance with changing FDA/ICH regulations.
May lead and manage tasks of junior Regulatory Operations personnel, including contractors.
Qualifications

Qualified candidates must have:

Required: Bachelor degree in a related field.
Preferred: Advanced degree in a related field.
7 or more years regulatory affairs or regulatory operations experience within the pharmaceutical or biotechnology industry.
Extensive global regulatory experience with INDs/CTAs, NDAs/BLAs, MAAs, lifecycle management, interactions with Health Authorities and working with project teams.
Experience in assisting with implementation and maintenance of document management systems.
Extensive knowledge and experience with Microsoft Office Suite, Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems.
Strategic with an operational approach and the ability to think outside the box.
Ability to manage multiple tasks in a fast-paced environment.
Excellent problem-solving and organizational skills while maintaining a high level of attention to detail.
High energy level, willingness and ability to work in a hands-on capacity to adapt and respond to a rapidly changing environment.
Ability to work effectively in a project team environment.
Effective verbal and written communication skills, excellent interpersonal skills, and a team approach.
Ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.
Strong business acumen and ability to make sound decisions that contribute positively to the business.
Strong written and verbal communication skills.
Self-motivated and able to work independently.
Exceptional time management skills.
Proven team player who can focus on and drive goal completion.


*CO candidates may not be considered
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