Regulatory Associate

Regulatory Associate
  • $1 - $37.32 per Hour
  • Temporary
  • Rockville MD, US Rockville MONTGOMERY US 20852
Job Ref: JO000119320
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 21 June 2021

Regulatory Associate
Job Purpose*
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.
Key Responsibilities:
• 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.

25/04/2022 12:00:00
USD 1.00 37.32 Hour
Contact Consultant:
Angela Leick

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