Regulatory Project Manager

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.
• Responsible for Nonclinical strategy development, with managerial support, for Nonclinical submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and lifecycle management activities in accordance with the applicable regulatory & scientific standards
• Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to nonclinical drug development and registration, to expedite the submission, review and approval of global Nonclinical applications.
• Ensures information submitted in clinical/marketing applications meets regional requirements with minimal unanticipated questions.
• 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,harmonisationand 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
• May be identified as Nonclinical Regulatory expert in a specific subject area.
• 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.

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 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.