Regulatory Associate job in Rockville, USA

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Last Name*

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First Name*

Last Name*

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First Name*

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Job type: Permanent

Discipline: Officer /Associate, Operations, CMC

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Regulatory Associate with a pharmaceutical company located in Rockville, MD.

Job Description:

Ensure approved product dossiers are maintained in a state of compliance with respect to the manufacturing, testing, storage and distribution operations.
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.

Skills and Requirements:

BS/BA in Technical or Analytical discipline - Base level to ensure understanding of regulatory/ technical knowledge required to effectively ensure minimal compliance requirements are met
MS in Quality/Regulatory - Provides for greater depth and breadth in understanding and applying regulatory science to pharmaceutical manufacturing operations
Minimum 1-5 years industry experience in biopharmaceutical/biologics manufacturing environment. 0-3 years prior experience in regulatory functions. -- Highly regulated and complex environment, ability to effectively manage workload
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

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

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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