Regulatory Affairs Associate I

Shire Pharmaceuticals, Inc.
Regulatory Affairs Associate I

Founded in 1986, Shire Pharmaceuticals, Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.

Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our continued growth, we currently have a need for a Regulatory Affairs Associate I in our Wayne, Pennsylvania location.


Description
Under the direction of the Senior Regulatory Affairs Manager, the Regulatory Affairs Associate provides support and assistance in the collection, preparation, and assembly of documentation required for INDs and Amendments, NDAs and Supplements, and other submissions to regulatory agencies.

Key Responsibilities
?Requests, reviews and interprets for clarity, accuracy and completeness IND/NDA/Safety Annual Report components, and compiles and submits the reports to the FDA within the specified time frame.
?Assists Safety Unit in reporting and follow-up of all adverse drug experiences received by Shire for one or more therapeutic areas.
?Performs routine IND/NDA maintenance. May make non-critical calls to FDA Review Divisions.
?Interacts with personnel within or outside of Shire to ensure the timely and comprehensive receipt of information required for regulatory submissions.
?Delegated to project team liaison tasks.
?Reviews clinical investigation-related documents for accuracy and compliance with GCPs (study protocol, investigator brochure, informed consent, etc.).
?Reviews advertising and promotional pieces for compliance with regulations.
?Conducts regulatory Internet research and provides the department with any updates concerning regulatory guidelines.
?Performs administrative functions as directed by Management to support projects.

Education and Experience Requirements
?Bachelor?s degree is required. Scientific/health care field preferred, but not required.
?Generally has at least three years of drug development experience within a regulated environment.
?Ability to read, analyze and interpret scientific and technical journals, as well as regulatory documents.
?Ability to respond to inquiries or complaints from regulatory agencies.
?Ability to draft basic regulatory correspondence.
?Experience maintaining regulatory files is a plus.
?Working knowledge of FDA regulations and guidelines, as well as reporting systems is required.
?Strong knowledge of MS Word, Excel, Access, PowerPoint, and Outlook.
?Basic knowledge of MR Project is preferred.
?Must have excellent document organization and formatting skills.
?Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
?Must be able to interact and communicate effectively with visitors, vendors and individuals at all levels of the organization.
?Must be able to work in a fast paced environment with demonstrated ability to effectively handle multiple competing tasks and demands.
?Ability to communicate effectively with contract organizations and respond to inquiries or complaints.
?Excellent written and oral communication skills.
?Ability to work independently, take initiative and complete tasks to deadlines.
?Ability to work successfully within a cross-functional team.


To create a profile and apply online, go to http://v2.projectix.com/shire/jobboard/NewCandidateExt.aspx?__JobID=1058 Additional information can be found at www.shire.jobs

Shire is committed to providing high quality, competitive and appropriate health care benefits for employees and their families.

Shire is an Equal Employment Opportunity and Affirmative Action Employer.

To Apply for this position, please CLICK HERE