Regulatory Project Manager

3 weeks ago

Collegeville, United States GSK Full time

**Site Name**: USA - Pennsylvania - Upper Providence

**Posted Date**: Jun 18 2024

Are you looking for a role where you can showcase your process improvement skills? If so, this is the job for you.

As Regulatory Project Manager you will be responsible for the Nonclinical regulatory activities in the investigational, late phase development and/or commercial lifecycle management of GSK products.

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

- Responsible for the global Nonclinical regulatory activities for assigned projects and responds readily to changing events and priorities.
- Works in cross-functional matrix project teams, which include colleagues from regulatory, preclinical (IVIVT/Research Units/RDC) and Clinical Operations ensuring adequate interaction and partnership in order to define proper regulatory Nonclinical filing strategy.
- Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
- Ensures regulatory compliance is maintained and shares best-practices and learnings within the Nonclinical Regulatory teams and other impacted functions.
- Engages in Nonclinical Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency)
- Will sometimes deliver Nonclinical regulatory strategy to support major audits with managerial support.

**_ Why you?_**

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

- BSc in Life Sciences or a related scientific discipline
- Nonclinical regulatory affairs or nonclinical drug development experience with direct involvement in regulatory submission preparation across all stages of development through to life cycle submissions.
- Knowledge of drug development and may have a specialized area of expertise.
- Knowledge of worldwide Nonclinical regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.

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

- M.Sc
- 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.
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects.
- Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
- Strong interpersonal, presentation and communication skills with established internal networks
- Proactively seeks out and recommends process improvements
- Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
- Demonstrated ability to handle global Nonclinical issues through continuous change and improvement
- Developing experience in major filing activities (MAA/NDA/BLA, key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development)

LI-GSK

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.

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,

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