Regulatory Documentation Specialist I

Summary

Maintains regulatory documentation and filing systems in support of the Biopharma North America regulatory team. Maintains accurate files of health authority correspondence in paper and electronic formats as needed and word processing submission documents as needed. This position will support the product managers to meet business objectives for the overall regulatory team.

Primary Responsibilities

• Perform updates, facilitate SME reviews, and ensure proper hard copy and electronic filing of Regulatory Submission Documents (RSDs) as needed.
• Ensure that regulatory records are properly filed and accessible in the appropriate documentation system.
• Assist in maintaining SOPs/IBPs that describe the Regulatory Affairs filing system and other RA SOPs/IBPs files and maintenance.
• Manage requests for translations and legalizations with vendors.
• Respond to requests for records by researching and reviewing internal documentation, including the retrieval of documents from off-site storage.
• Communicate with regulatory personnel regarding regulatory records.
• Process and track all invoices to ensure prompt payment.
• Request Certificate of Foreign Governments (CFG) and Certificate of Pharmaceutical Products (CPP) from FDA
• Serve as primary contact with Accounts Payable.

Note: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Manager and supervisors may assign other duties as needed.

Knowledge, Skills, and Abilities

• Basic knowledge of applicable laws and regulations.
• Ability to work with limited supervision and initiate contacts essential to submission preparation.
• Ability to manage multiple and possibly conflicting priorities.
• Ability to work as part of the regulatory team to meet group objectives.
• Ability to review a document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.
• Ability to clearly communicate verbally and in writing.
• Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents.
• Ability to work with other computer systems for filing supplements and reports.
• Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives.

Education Requirements

Bachelor’s degree in a relevant discipline, or equivalent work experience.

Experience Requirements

0 to 1 year of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience.

Equivalency

Depending on area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirement. Example: if a job level requires a Bachelors degree plus 4 years experience, an equivalency could include 8 years, an Associates degree with 6 years experience, or Master's or a Master's degree with 2 years experience.

Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.