Senior Manager, Regulatory Operations

• As an integral member of Otsuka’s submission level publishing team, provides regulatory publishing and submission leadership.

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

• Acts as primary liaison between all R&D functions as the submission lead for designated applications (e.g., NDA, MAA, supplements and amendments).

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

• Interacts extensively with the RA Department and with other functions to accurate content is submitted.

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

• Collaborates with alliance partners to achieve corporate objectives for shared dossier development and submission.

• Develops assigned submission level publishing work instructions.

• Establishes and builds collaborative relationships with colleagues.

• Contributes to design and implementation efforts to maximize electronic submissions efficiency and effectiveness.

• Prepares, submits, tracks, indexes, and archives paper and electronic submissions / application dossiers.Responsible for organizing and maintaining regulatory files. Able to provide regulatory submission support to other departments.

• Demonstrates flexibility in dealing with change and diversity.  

• Knowledge Requires knowledge of FDA/EMEA regulations and guidance for electronic and paper submissions.

• Expert knowledge and experience in electronic submissions (eCTD, ICH).Working knowledge of the drug development process, drug laws, regulations, and guidelines.

• Strong computer skills with demonstrated experience and ability in Documentum, Microsoft Office suite (Word, Excel, Access, and PowerPoint), and Sharepoint.Working knowledge of Liquent Insight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox.

• Recent experience with NDAs / MAAs is essential.Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, life-cycling, and archiving (eCTD) sequences.

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

• Well defined written and oral communication skills.

• Demonstrates flexibility in dealing with change and diversity. 

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

• Successfully engaged in multiple initiatives simultaneously.

• Able to solve complex issues through innovative problem solving.

• Bachelor’s of Arts or Science degree

• Minimum of 6 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions.

• 7 years of professional experience. 

• Certification is a plus (such as Regulatory Affairs Professionals Society (RAPS).

• Prior project management and NDAs/MAA experience preferred

• Travel and onsite work: approximately 10%

Competencies
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 …