As a Regulatory Compliance Specialist you have the responsibility and accountability to support the Regulatory Compliance programs at site. The Regulatory Compliance Specialist supports the Regulatory Compliance Lead to ensure compliance objectives are met with respect to regulatory submission processes, change and deviation management, and routinely evaluates and communicates Regulatory Intelligence.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Responsible for reviewing all proposed technical changes via Change Control System, and providing guidance to the impact on regulatory submissions, and using this information to assist change owners in the assessment of scope for the change.
• Responsible for supporting Change Owners with RIS (Regulatory Implementation Strategy) Meetings for Change Controls with Regulatory/Supply impact.
• Participate in all Quality related Audits (Regulatory, Corporate Internal Audits, etc). Assists, when required, in the drafting of necessary correspondence with regulatory agencies, which is related to regulation inspections or other GMP matters.
• Engages with the site to promote a culture of awareness and understanding of regulatory compliance trends and continuous improvement initiatives, and how to embed regulatory compliance into routine site activities.
• Supports and/or assures completion of annual product reviews.
• Participate in monthly PTRT (Product Technical Review Team) meetings and Regulatory (CoP) Community of Practice meetings
• Participate in monthly Quality Council meetings to provide Regulatory Updates.
• Coordinates efforts with GSK Regulatory Affairs and other business departments to assure all mandatory licenses and registrations (BLA’s/MAA’s) are kept current and in compliance with relevant health authority requirements.
• Liason between Site and LOCs for all filed markets
• Responsible for reviewing all monthly QRI reports/business evaluations, assessing the impact to site, and actioning against gaps identified.
• Responsible for reviewing vendor change notifications and deviations to assess impact to registered details.
• Ensure regulatory requirements are captured and maintained across GSC Biopharm supply chain via TTS.
• Support regulatory certification/re-certification activities for all applicable files in approved markets.
• Report and drive resolution of cGMP/Regulatory compliance issues via declaration requests required by LOC.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS/BA
• 4+ years of experience in cGMP environment
• 2+ years of regulatory affairs or quality or regulatory compliance role

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Prior experience with licensed biopharmaceutical or biological products.
• Knowledge in GMP’s, FDA, MHRA, EMA and other regulatory agency requirements for biopharmaceutical validation and operations, analytical and stability functions and compliance.
• The incumbent is responsible for adhering to all GSK safety guidelines and procedures.
• Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements preferred.
• Good written communication, organizational, and computer skills.
• Good interpersonal and verbal skills required.
• Able to prioritize and decide appropriate course of actions. Effective at implementing decisions.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.
  

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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