Vaccines Regulatory Associate Manager, Product

1 week ago


Cairo, Cairo, Egypt GSK Full time

Site Name:
Egypt - Cairo

Posted Date:
Apr 3 2023

Job Purpose:

  • Responsible for the GRC regulatory delivery activities assigned Rx and/or Vx projects across dosage forms with mínimal input from line manager.
  • Supports Global Regulatory by producing appropriate components for global regulatory dossiers with mínimal input from line manager.
  • Has training/mentoring responsibilities for new staff on established departmental processes.

Key Respon
sibili
ti
es:

  • With mínimal input from manager, executes agreed dossier strategy.
- . With mínimal input from manager, manages multiple project assignments (e.g., Product Variations); dossiers will range in complexity.

  • With mínimal input from manager, completes data assessment to ensure dossier is fit for purpose.
  • With mínimal input from manager, identifies risks associated with submission data and information packages.
  • Communicates with line manager to identify issues that have business impact.
  • May have dossier review responsibilities for peers and may identify improvement opportunities for Regulatory processes, policies, and systems.
  • Understands internal/external Regulatory environment.
  • Actively builds an organisational network.
  • Communicates across GSK, with mínimal input from manager regarding project and policy issues ensuring optimum position for GSK.

_ Why you?_

Basic Qualifications:

  • Bachelor's degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
  • Minimum 68 years of relevant experience.
  • Broad understanding of the pharmaceutical industry, drug development environment, and
    R&D processes and objectives.
  • Global/ EMAP Regulatory submission experience
  • Knowledge of regulatory agency guidelines.
  • Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
  • Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience.
  • Ability to build effective working relationships and work in a matrix environment effectively.
  • Ability to think flexibly inorder to meet constantly shifting priorities and timelines.
  • Service orientation, customer focused.
  • English language skills.
  • Knowledge of drug development and manufacturing and supply processes.
  • Knowledge of worldwide CMC regulatory requirements.


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.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.


Contact information:

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