Project Manager, CMC Regulatory Affairs

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware RD, UK - London - Brentford, USA - Massachusetts - Waltham

Posted Date: Mar

365216 Project Manager, CMC Regulatory Affairs

We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our BioPharm CMC Regulatory Affairs Group. At GSK, our BioPharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals products. This role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity. You will play a key part in GSK's commitment to making a difference to patients' lives enabling them to Do More, Feel Better and Live Longer.

This role can be based at our sites at Ware - Hertfordshire, GSK House - London, Upper Providence, Pennsylvania - USA OR Waltham, Massachusetts - USA, however this role will interact across our global network.

Flexible work arrangements can be considered consistent with GSK Performance with Choice policy. (Will share policy and discuss during initial Teams Meeting interview.)

In this role you will

• Manage, or be responsible for, the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
• Be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions (IND/IMPD/CTA) through to marketing applications (BLA/MAA) and post approval activities.
• Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite submission, review and approval of global CMC applications.
• Ensure that all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Also, ensure that information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
• Work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development 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.
• Engage in CMC Subject Matter Expert activities internally (for increased compliance, harmonization and efficiency).
• Sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.

Why you?

Qualifications & Skills:

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

• Bachelors degree (or equivalent) within a relevant subject such as pharmacy, biotechnology, chemistry or a related scientific discipline, or demonstrable industry experience.
• One or more years of Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions.
• Has gained, through years of experience, knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.

Preferred Qualifications & Skills:

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

• Strong verbal and written communication skills with good attention to detail.
• Excellent team working abilities and effective influencing skills.
• Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
• Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
• Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
• The ability to successfully influence and negotiate issues at a senior level within your organization and with regulatory agencies in a variety of settings.
• Experience of Agency interactions and/or submissions in US, EU, Japan and China.

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more:

Annual Report 2021

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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