The job holder has responsibility and accountability for ensuring approved product dossiers are maintained in a state of compliance with respect to the manufacturing, testing, storage and distribution operations at Rockville Biopharm facilities.
• Assist Biopharm site regulatory submission preparation & review of global submissions, variations/supplements for products produced by the Biopharm site. This includes both IND and approved commercial products.
• Support Response to Questions (RTQ’s). Support Market Specific Requirements (MSR’s). Support renewals.
• Support change notifications from Vendors by assessing regulatory impact.
• Support changes to site specifications
• Initiate change controls for new market submissions.
• Support Annual Reports for commercial products. Support Periodic Product Review reports for commercial products.
• Support change control assessments; provide advice and approval. Initiate RADARs and support Regulatory Implementation Strategy (RIS) meetings.
• Support adherence to current regulatory requirements by supporting monthly Quality Regulatory Intelligence (QRI) meetings. Support Quality Alerts.
• Attend monthly Regulatory Community of Practice (CoP) forums.
• Support regulatory inspections from all health authorities.
• Participate in self-inspections to ensure PAI readiness.
• The incumbent is responsible for adhering and promoting safety guidelines and procedures.
Knowledge/ Education / Previous Experience Required:
• Minimum BS/BA in Technical or Analytical discipline
• Minimum 1-5 years industry experience in biopharmaceutical/biologics manufacturing environment.
• 0-3 years prior experience in regulatory functions.
• Good understanding and interpretation of Global regulations pertaining to the manufacture, holding, and distribution of biopharmaceuticals/biologics.
• Extensive working knowledge of marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
• Good working knowledge of regulatory affairs, including submissions/supplements/variations and approved dossiers.
• Demonstrated ability in conformance review of registered documentation and practices.
• Comprehensive knowledge and application of the Quality Management system (QMS).
• Excellent written and verbal communication skills.
• Demonstrate Project Management and organizational skills.
• Good working knowledge of applicable systems including electronic dossier submission systems
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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