CMC Regulatory Affairs Manager

If you are dedicated to ensuring supply continuity of medicines to patients, then this role presents an exciting opportunity to do just that!

As a CMC Regulatory Affairs Manager, you will be a member of the CMC Small Molecules, Mature Products management team managing a team of CMC regulatory professionals. These teams are responsible for lifecycle maintenance and network strategy activities for GSK's small molecules portfolio encompassing products aligned to classic and established, respiratory and HIV brands.

Responsibilities:

• Responsible for the strategy development and oversight of meeting CMC regulatory deliverables to support uninterrupted supply of medicines through compliant Marketing Authorizations.

• Act as part of the US Local Operating Company to support regulatory submissions to FDA.

• Input CMC regulatory strategy to support major inspections or quality incidents.

• Understand, interpret and advise cross-functional teams on US and global regulations, guidelines, procedures and policies relating to CMC lifecycle changes and variations in relation to the manufacture of pharmaceutical products, to expedite submission, review and approval of global CMC regulatory applications.

• Work in cross-functional matrix project teams, which include colleagues from the wider regulatory organization, quality and manufacturing.

• Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.

• Influence your team members' professional development, building capabilities within the department.

Basic Qualifications:

• Doctorate, Masters, or Bachelors degree in pharmacy, chemistry or related scientific discipline

• Experience with drug development, and/or manufacturing and supply

• 2+ years' experience in CMC regulatory including developing strategy and authoring CMC dossier components (CTD Modules 2 and 3) for US and global regulatory submissions (SNDAs, Amendments, Variations, Global Marketing applications)

• Experience with US requirements for pharmaceutical products

• Experience developing strategy, managing multiple projects and multiple cross-functional project teams simultaneously

Preferred Qualifications:

• Experience with global regulatory requirements for pharmaceutical products

• Experience of evaluation and provision of CMC regulatory advice to in-licensing and divestment projects

• Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines

• Demonstrated ability to lead cross-department initiatives with effective influencing skills

• Demonstrated ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives

• Commercially astute and politically sensitive and able to manage sensitive and confidential issues

• Demonstrated ability to influence the global internal/external regulatory environment

• Ability to motivate and lead others

This is a hybrid opportunity available in Durham, NC or Upper Providence/Collegeville, PA, USA.

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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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