Regulatory Associate

Highly Competitive Salary
  1. Permanent
  2. Officer /Associate, Operations, CMC
  3. United States
Rockville, USA
Posting date: 11 Jan 2021
This vacancy has now expired

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.