Project Manager, CMC Regulatory Affairs

    • Collegeville, PA

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware RD
Posted Date: Jul 8 2020
CMC Reg project manager

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 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 multiple projects/teams simultaneously 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.

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.

Closing date for applications: Friday 3rd July2020

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

Why you?
Basic Qualifications:
In this role you will require a bachelor degree (or equivalent) within a relevant subject such as pharmacy, biotechnology, chemistry or a related scientific discipline.

You will also possess:

o 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 Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
o Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
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.

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.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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
(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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