QA / Regulatory Specialist

Proclinical is currently recruiting for a QA/Regulatory Specialist with a global pharmaceutical company located in Rockville, MD. Successful candidate will support Response to Questions (RTQ's), Market Specific Requirements (MSR's) and renewals.

Job Responsibilities:

• Support change notifications from Vendors by assessing regulatory impact.
• 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.
• Adhere and promote safety guidelines and procedures.

Skills and Requirements:

• BS/BA 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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