Position Summary

The Senior Regulatory Assoicate assists the regulatory representative to project teams for assigned projects or products and by providing regulatory tactical support and strategy under guidance from manager. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug in conjunction with more senior members of the department.

Job Responsibilities

Assists Managers, Directors, or Senior Directors of Regulatory Affairs in providing guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.

• Under guidance from manager, recommends regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products.
• Conducts regulatory research and intelligence to appropriately guide Project Teams.

Assists in ensuring the overall quality of regulatory submissions.

• Manages, Reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards under direction from manager.
• Provides appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions.

Works on initiatives as a regulatory representative

Knowledge

• Knowledge of drug development process.
• Solid understanding of medical and clinical practices
• Strong understanding of medical concepts and terminology, including strong knowledge of FDA Part 11 and global regulations.
• Knowledge of CFRs, ICH and FDA regulations.
• Knowledge of submission preparation and management

Skills

• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat.
• Strong communication skills.
• Knows how/when to apply organizational policy or procedures to a variety of situations.

Education and Related Experience

• Bachelors degree in Life Sciences or related field
• Minimum 0 to 2 years of pharmaceutical industry in regulatory affairs
  

Travel 10%

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 .