Regulatory Affairs Specialist II
University of Massachusetts Medical School
Mattapan, Massachusetts
regulatory
regulatory
regulatory submissions
biologics
management
manufacturing
event
departmental
operations
r&r
coordination
research
materials
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March 21, 2023
University of Massachusetts Medical School
Mattapan, Massachusetts
FULL_TIME
Overview:
GENERAL SUMMARY OF POSITION:
Part-time candidates will be considered for this opportunity.
Responsibilities:
MAJOR RESPONSIBILITIES:
Qualifications:
REQUIRED QUALIFICATIONS:
Additional Information:
Experience with IQVIA preferred.
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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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