Regulatory Submissions Associate

Sr. REGULATORY SUBMISSIONS ASSOCIATEis responsible for activities related to REGULATORY PUBLISHNG AND SUBMISSION support to fulfil GRA needs. Seeks to contribute into innovation process while supporting GRA strategy and deliverables. Ensures adherence to established business standards within GRA and cross- functional stakeholders. Collaborates with other global and regional development organizations, affiliates, and in-licensed partners to ensures that project/department milestones/goals are being met.

• As an integral member of Otsukas regulatory operations team, provides REGULATORY PUBLISHING AND SUBMISSION SUPPORT
• Ensures assigned submissions are made with quality and on-time.
• Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions.
• 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.
• Responsible for preparation, submission, tracking, and archival of paper and electronic submissions.
• Assists with development of assigned regulatory operations work instructions.
• Establishes and builds collaborative relationships with colleagues.
• Represents Regulatory Submissions on various Process Mapping Teams (i.e., INDs, NDAs, Clinical Study Reports).
• Responsible for organizing and maintaining regulatory files.
• Provides regulatory publishing support to other departments.

Location - Candidate can either live a commutable distance from Princeton, NJ or Rockville, MD

Required

• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions.
• Strong knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, 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., Lorenz DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)
• Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.
• Recent experience with NDAs (New Drug Application) / MAAs (Marketing Authorization Application) is essential

Skills

• Demonstrated performance in managing and producing quality time-intensive deliverables.
• Highly developed project skills
• Proven ability to solve complex issues through innovative problem solving
• Well defined written and oral communication skills
• Knows how/when to apply organizational policy or procedures to a variety of situations
• 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.

Education

• Bachelors of Arts or Science degree or equivalent professional experience
  Experience
• Minimum 2 years for Associate-level (or minimum of 4 years for Sr. Associate level) of regulatory operations experience and in-depth first-hand experience with application electronic submissions.
• Certification is a plus (such as Regulatory Affairs Professionals Society (RAPS).
• Prior project management experience is preferred

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyondunder any circumstancesfor patients, families, providers, and for each other. Its this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho the achievement, completion, and discovery of truth; and Sozosei pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .