Regulatory Project Manager, Strategy - CMC RA Small Molecules Mature Products

Regulatory Project Manager, Strategy - CMC RA Small Molecules Mature Products Business

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
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Position Summary:
As Regulatory Project Manager, Strategy you will be responsible for the provision of CMC support to a defined portfolio of marketed drug substances and products (small molecules) for global markets.  This is an interesting and fast paced role which will provide opportunity for you to use and develop your CMC technical skills and regulatory knowledge for all regulatory active countries. We value people who are practical, collaborative, and focused on patient impact. This role gives visible influence on product life cycles, clear growth opportunities, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Key responsibilities include maintenance of the global regulatory information for assigned products by leading CMC Regulatory Matrix teams and representing CMC in the cross-functional Regulatory Matrix Teams.  In delivering your objectives you will partner with the manufacturing organisation (both Technical and Quality) to provide strategic regulatory advice for change controls, develop regulatory strategies and plans (through to implementation), and lead authoring of the variation dossiers and responses to Regulatory Agency questions, ensuring all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. 

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

• Develop CMC strategy for CMC submission documents to support small molecule marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
• Ensure information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.   
• Prepare, review and quality-check CMC content for regulatory filings, post-approval variations, and maintenance submissions.
  Act as primary U.S. regulatory contact for agency interactions, written questions, and meeting preparation.
• Advise cross-functional teams on U.S. global CMC regulatory requirements and timelines to support supply continuity.
• Manage regulatory risk by identifying gaps, proposing mitigations, and coordinating actions with stakeholders.
• Ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams and other impacted functions. 
• Share CMC subject matter expertise and support continuous improvement of regulatory processes.

Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
 

• Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline, or equivalent experience.
• Minimum of 2 years’ experience in CMC regulatory affairs focused on small molecules, including lifecycle management and post-approval activities or closely related discipline.
• Direct experience preparing or contributing to CMC sections of regulatory submissions for the U.S. market.
• Six or more months experience with U.S. regulatory requirements and guidance relevant to CMC, including Good Manufacturing Practices.
   

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

• Advanced degree (Master’s or PhD) in a relevant scientific field.
• Experience leading U.S. regulatory interactions and meeting preparation with the FDA.
• Demonstrated ability to work in cross-functional teams with development, manufacturing and quality colleagues.
• Strong written and verbal communication skills with attention to detail.
• Experience managing multiple product dossiers and competing priorities in a matrix environment.
• Experience supporting inspections or providing regulatory input for manufacturing changes.
  Knowledge of electronic dossier formats and submission processes.
• Proven ability to influence stakeholders and negotiate technical-regulatory resolutions.
   

Working Model:

• This role is hybrid. You will be expected to be on-site regularly and collaborate with colleagues across sites and regions.
   

Location:

This role can be based at Durham, NC or Collegeville, PA.

#LI-GSK

Skills

Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership

 

 

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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