CMC Development Projects Regulatory Project Manager

Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK?  If so, this Chemistry, Manufacturing and Controls (CMC)  Development Projects Regulatory Project Manager role could be an ideal opportunity to explore.

As a CMC Development Projects Regulatory Project Manager you will manage multiple projects and teams simultaneously and will provide assessments and conclusions/action plans within and across departments.  You’ll identify risks associated with submission data and information packages, and lead in the creation, maintenance and continuous improvement of Regulatory processes, policies and systems.

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

• Responsible for global CMC regulatory activities for assigned projects and to respond readily to changing events and priorities.
• Responsible for CMC strategy development, with managerial support, for  CMC submission documents  from early-phase clinical submissions through to marketing applications and early-lifecycle activities.
• Understand, interpret and sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, expediting the submission, review and approval of global CMC applications.
• Work in cross-functional matrix project teams, which include colleagues from regulatory, development, 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.

Why you?

Basic Qualifications:

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

• Bachelor’s Degree in pharmacy, chemistry or related scientific discipline.
• Minimum experience of 2 years in drug development/manufacturing processes and may have a specialized area of expertise.  
• Minimum experience of 1 year in CMC regulatory affairs or product development experience with direct involvement in regulatory submission preparation.

Preferred Qualifications:

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

• Broad-based knowledge across regulatory functions to understand wider implications of emerging issues across projects.
• Experience with influencing and negotiating within your organization as well as regulatory agencies in a variety of settings.
• Ability to find innovative solutions to complex problems and involvement in continuous-improvement initiatives.
• 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.
• Strong verbal and written communication skills with good attention to detail.
• Excellent team working abilities.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to