Regulatory Systems Specialist

Rockville, MD
January 11 2021
Organization Type
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 GSK safety guidelines and procedures.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in technical or analytical discipline

  • M inimum 1-5 years industry experience in biopharmaceutical/biologics manufacturing environment. 0-3 years prior experience in regulatory functions.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Good understanding and interpretation of Global regulations pertaining to the manufacture, holding, and distribution of biopharmaceuticals/biologics.

  • Extensive working knowledge of GSK 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 system

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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