Senior Manager, Regulatory Operations

Job Summary

The Sr. Mgr 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

Collaborates with alliance partners to achieve corporate objectives for shared dossier development, submission, and archival activities

Supervises staff 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

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

Minimum of 7 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions

Demonstrated performance in managing and producing quality time-intensive deliverables

Strong influencing skills and experience with outsourcing

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 leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful…