GSK currently has an opening for a Regulatory Systems Lead in Rockville, MD. In this role, you'll be responsible and accountable for ensuring approved product dossiers are maintained in a state of compliance with respect to the manufacturing, testing, storage and distribution operations at GSK Rockville Biopharm facilities.Key Responsibilities:
Why you? Basic Qualifications:
- Responsible for 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.
- Responsible for reviewing change notifications from Vendors to assess 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.
- Responsible for overseeing adherence to current regulatory requirements by managing monthly Quality Regulatory Intelligence (QRI) meetings. Management of 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.
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- BS/BA Degree
- 4+ years industry experience in biopharmaceutical/biologics manufacturing environment.
- 2+ 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 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 systems
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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