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