RA Compliance Manager

Basic qualifications:

Preferred qualifications:

Details:

Regulatory Compliance Manager

GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical and consumer healthcare companies and is committed to improve the quality of human life by enabling people to do more, feel better and live longer.

In Malaysia, GSK has established a strong presence for over 50 years and is home to our operations in the area of pharmaceuticals, consumer healthcare, manufacturing, and Business Services Centre. GSK employs over 1000 staff in Malaysia.

GSK is an exciting, rewarding and dynamic place to work. We thrive to be different from the conventional corporate ways of working. We pride ourselves on exemplary leadership and sense of community, and we offer a great platform for your personal and career development.

GSK Global Manufacturing & Supply

GSK's Global Manufacturing & Supply (GMS) plant produces leading consumer brands, services 13 global markets including Australia and New Zealand and is a leader in Good Manufacturing Practice and 'Premise/Factory of Choice" for industrial excellence in the region.

Job Purpose

We are currently recruiting for a Regulatory Compliance Manager to be part of the QA team. This role will mainly be responsible on managing the Regulatory Compliance section within the GMS Quality Department to ensure regulatory conformance of the site is maintained.

Key Responsibilities

  • Assess and review all change controls associated with equipment, methods, documents and processes associated with New Product Introduction (NPI) or other changes, for regulatory impact and define regulatory strategies for the change
  • Provide effective and timely support of NPI initiatives to facilitate timely and accurate submission of the registration dossiers and regulatory approval
  • Manage, train and coach regulatory compliance staff
  • Gather regulatory intelligence on new requirements and provide specialist advice on the implication to the business
  • Support site change, batch release, investigations, and other initiatives through the provision of regulatory advice

Key Responsibilities

  • Degree in Pharmacy, Science or equivalent.
  • At least 6 years' experience in regulatory affairs
  • Extensive knowledge of product registration requirements
  • Extensive experience with the product dossier compilation and/or registration process
  • Knowledge of quality and manufacturing processes preferred
  • Good communication and interpersonal skills
  • Good time management and project management skills
  • Able to work independently.

Contact information:

You may apply for this position online by selecting the Apply now button.

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