Site Name: UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence
Posted Date: Jan 7 2025
Job Overview
Are you looking for a role where you can showcase your project management 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.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
1. Responsible for the global Nonclinical regulatory activities for assigned projects and responds readily to changing events and priorities.
2. 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.
3. 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.
4. Ensures information submitted in clinical/marketing applications meets regional requirements with minimal unanticipated questions.
5. 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.
6. 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.
7. Ensures regulatory compliance is maintained and shares best-practices and learnings within the Nonclinical Regulatory teams and other impacted functions.
8. Engages in Nonclinical Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
9. 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:
1. BSc in Life Sciences or a related scientific discipline.
2. 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.
3. Knowledge of drug development and may have a specialized area of expertise.
4. 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:
1. M.Sc. in Life Science or related scientific discipline and/or Regulatory Affairs Certification (RAPS).
2. 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.
3. Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
4. Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
5. Strong interpersonal, presentation and communication skills with established internal networks.
6. May be identified as Nonclinical Regulatory expert in a specific subject area.
7. Proactively seeks out and recommends process improvements.
8. Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
9. Demonstrated ability to handle global Nonclinical issues through continuous change and improvement.
10. Developing experience in resource management (e.g., identification and definition of projects requiring nonclinical regulatory resource).
11. Developing/Significant experience managing Nonclinical regulatory documents to support lifecycle maintenance and mature product submission content.
12. Developing experience in major filing activities (MAA/NDA/BLA, key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development).
Closing Date for Applications: 21st January 2025 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV 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.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.
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.
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 neurodiversity, 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).
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