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CMC Regulatory Affairs Project Manager

Employer
GSK
Location
Rockville, Maryland; Waltham, Massachusetts
Salary
Competitive
Closing date
Sep 24, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Job Type
Project Manager
Organization Type
Pharma
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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 and Cell & Gene Therapy 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, Waltham Massachusetts, Rockville Maryland or at Upper Providence, Pennsylvania, USA, however this role will interact across our global network.

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

o You will manage, or be responsible for, the global CMC regulatory activities for one or multiple projects/teams and respond readily to changing events and priorities.

o You will be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and post approval activities.

o You will need to 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.

o You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development and manufacturing.

o You will 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:

In this role you will require a bachelor's degree (or equivalent) within a relevant subject such as pharmacy, biotechnology, chemistry or a related scientific discipline.

You will also possess:

o Minimum of one year experience in 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.

o One or more years' experience working with worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.

o One or more years' experience related to the development and implementation of regulatory strategies and evaluate the potential impact of them on overall project/product strategy.

Preferred Qualifications:

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

o Strong verbal and written communication skills with good attention to detail.

o Excellent team working abilities and effective influencing skills.

o Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.

o 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.

o Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.

o Experience of Agency interactions and/or submissions in US, EU, Japan and China.

o The ability to successfully influence and negotiate issues at a senior level within your organisation and with regulatory agencies in a variety of settings.

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.​



With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.​



Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership ofgoals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.

Interested in joining the team?

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Thank you for your interest in this opportunity.

*LI-GSK

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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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