Manager, Regulatory Operations

Remote

Full time

R12920

The Manager Regulatory Operations is responsible for the coordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency.

• As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts

• Ensures assigned submissions are made with quality, on-time, and within established budgets

• Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions

• Liaise with affiliates for coordinating and publishing defined content

• Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules

• Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements

• Ensures submission and archival activities

• Provides direction to staff and contingent workers to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards

• Oversees project team members for assigned submissions, including work assignments to vendor partners

• Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports)

• Develops and maintains assigned regulatory operations work instructions

• Establishes and builds collaborative relationships with colleagues

• Responsible for organizing and maintaining regulatory files

• Provides regulatory publishing guidance to other departments / functions

Required:

• Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions

• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions

• Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, life cycling, and archiving (eCTD) sequences

• Demonstrated performance in managing and producing time-intensive deliverables

• Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., Docu Bridge, InSight Publisher, Global Submit Validate, Global Submit Review, and ISIToolbox)

• Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and Share Point

• Knowledge in developing processes across multiple departments/divisions that leverage technology

• Recent experience with NDAs / MAAs is essential

• Demonstrated performance in managing and producing quality time-intensive deliverables

• Strong staff management skills

• Proven ability to solve complex issues through innovative problem solving

• Well defined written and oral communication skills

• Knowledge how/when to apply organizational policy or procedures to a variety of situations

• Demonstrated flexibility in dealing with change and diversity

• Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment

• Successful engagement in multiple initiatives simultaneously

• Certification (such as Regulatory Affairs Professionals Society (RAPS))

• Prior project management experience

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in…