CMC Regulatory Project Manager GlaxoSmithKline

Posted on 28 Oct

Experience

1 - 7 Years

Job Location

Cairo - Egypt

Education

Bachelor of Science(Chemistry), Bachelor of Pharmacy(Pharmacy)

Nationality

Any Nationality

Gender

Not Mentioned

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities

In this role you will:

  • Develop and deliver regulatory strategies for global, regional, and local market submissions, ensuring compliance with evolving regulations and scientific standards.
  • Provide expert guidance to multidisciplinary teams on regulatory requirements, policies, and guidelines related to the manufacture and control of medicinal products.
  • Support lifecycle management submissions, ensuring alignment with regional requirements and minimizing questions from Health Authorities.
  • Collaborate in cross-functional matrix teams working closely with Regulatory, Development, Quality, Technical, and Manufacturing stakeholders to define effective regulatory filing strategies.
  • Ensure continuity of market supply by managing regulatory aspects of product release.
  • Drive innovation and continuous improvement to respond to the evolving regulatory environment.
  • Share best practices and learnings across the CMC Regulatory teams and other impacted functions to enhance regulatory compliance and efficiency.


Desired Candidate Profile

We are looking for a professional with these required skills to achieve our goals:

  • Bachelor s degree (or equivalent) in pharmacy, chemistry, or a related scientific discipline.
  • Proven experience in CMC regulatory affairs or product development, including preparation of regulatory submissions for late-phase development and/or marketed product lifecycle management.
  • Strong understanding of drug development, manufacturing processes, and supply chain.
  • Knowledge of global CMC regulatory requirements, with a track record of delivering complex regulatory strategies and overseeing submission writing.
  • Excellent time management skills and the ability to prioritize multiple tasks in a fast-paced environment.

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

  • Master s or Ph.D. degree (or equivalent) in pharmacy, chemistry, or a related scientific discipline.
  • Regulatory Affairs Certification (RAPS) or equivalent professional certification.
  • Demonstrated expertise in influencing and negotiating with internal teams and regulatory agencies.
  • Experience implementing regulatory strategies that impact global projects and product plans.
  • Strong interpersonal, presentation, and communication skills, with a proactive approach to process improvement.
  • Recognized as a CMC Regulatory expert in a specific subject area, with the ability to lead through continuous change and improvement.

Company Industry

  • Pharma
  • Biotech
  • Clinical Research

Department / Functional Area

  • R&D
  • Research & Development

Keywords

  • CMC Regulatory Project Manager

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GlaxoSmithKline

Join our Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Group within Global Regulatory Affairs at GSK, where we play an essential role in ensuring uninterrupted access to life-changing medicines for patients worldwide.

As part of the CMC Regulatory Affairs team, you ll collaborate across Global Supply Chain (GSC), Technical, Quality, and Local Operating Companies to support lifecycle management of marketed small molecules. In this exciting role, you ll help shape regulatory strategies, drive sustainability initiatives that align with GSK s 2030 environmental goals, and deliver high-impact solutions that enhance the way we manufacture and control our medicines.

At GSK, we re committed to improving the quality of human life by enabling people to do more, feel better, and live longer. As a CMC Regulatory Project Manager, you ll contribute to this mission while advancing your career in an environment that fosters collaboration, innovation, and professional growth.

Join us to help shape the future of healthcare and make a difference in the lives of patients worldwide.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

Read More

https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/UK--London--New-Oxford-Street/CMC-Regulatory-Project-Manager_429428-2

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