Overview

GENERAL SUMMARY OF POSITION:

Responsible for the coordination and preparation of document packages for regulatory submissions for an FDA regulated Biologics research & manufacturing organization. Compiles all materials required for submissions, license renewal and annual registrations. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes.

Part-time candidates will be considered for this opportunity. 

Responsibilities

MAJOR RESPONSIBILITIES:

• Prepares paper and electronic regulatory submissions. Assists with the collection and verification of necessary clinical documents for completed studies in preparation for regulatory submissions.
• Visits study sites on a regular basis to ensure that the investigator is following the clinical protocol, the data are accurate and accurate accounts are kept of study drug usage.
• Receive adverse event reports, document appropriately, circulate and track internally, submit to FDA as needed. Submit Periodic Adverse Event Report for all licensed products every January.
• Reviews the Federal Register for items relevant to Biologics. Assess impact to MassBiologics activities and prepares summaries for management.
• Reviews labelling in preparation for submission to the FDA.
• Assist in auditing of manufacturing facilities, vendors, and clinical sites.
• Conducts regulatory review of routine change controls and executed validation protocols. Assigns appropriate reporting categories.
• Takes all product query calls.
• Reviews and revises departmental SOPs for regulatory compliance, may review organizational SOPs as appropriate.
• Resolves problems of a diverse scope efficiently and effectively and ensures critical matters are escalated to management and resolved in a timely manner
• Continuously assesses Regulatory Affairs operations and takes initiative to increase the efficiency of departmental operations.
• Performs other additional job related duties as required

Qualifications

REQUIRED QUALIFICATIONS:

• Requires a bachelor’s degree in a scientific discipline with a minimum 2 years of relevant experience or equivalent
• Ability to follow instructions precisely , recognize deviations, and recommend corrective action
•  Prior experience in a cGxP regulated environment. Strong working knowledge of FDA regulations, with an emphasis Biologics is required.
• Demonstrated ability to train and supervise others
• Ability to conduct complex troubleshooting 
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
• Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
• Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others 
• Demonstrated initiative through past experience
• Ability to work effectively both independently and as a member of a team
• Experience preparing documents for regulatory submissions is required
• May require some travel
• May require extended, and, at times unusual hours to meet business needs

Additional Information

Experience with IQVIA preferred. 

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