Regulatory Affairs Executive

Basic qualifications:

  • Doctor of Pharmacy
  • Computer literacy
  • Good Communication skills
  • Basic English skills

Knowledge:

  • Sound understanding of basic Regulatory guidelines both locally and internationally.
  • Enthusiasm of entrepreneurs
  • Improved and well channelled lobby strategy
  • Contributing with Passion and an unmatched sense of urgency

Complexity:

  • Need to be able to adapt quickly to constantly changing regulatory policies and environment
  • Ability to plan and organise work
  • Quick adaptation to continuously increasing responsibilities.

Preferred qualifications:

Details:

Job Family - Regulatory Affairs Management: Maintains the organisation's on-going relationships with regulatory commissions/authorities relating to clinical issues. Ensure compliance as required by regulatory commissions/authorities. Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints. Advances organisation positions with internal and external parties. In addition to the line management responsibilities, would be involved in the strategy across therapy areas.

Job Family Group - Regulatory: Performs audits to ensure that the organisation is in compliance with government laws and regulations. Directs the development of submissions of product registration. Interacts with regulatory agencies to answer questions regarding submissions. Responsible for the preparation, publication, and delivery of paper and electronic components of all submissions. This includes proper formatting bases on the agency requirements.

Essential Job Responsibilities:

  • Review registration dossier versus regulatory requirements and ensure its completeness
  • Prepare and compile registration package for Established Products, New Chemical Entities, Line Extension etc…
  • Dispatch dossier to local contacts and ensure timely submission to Regulatory Authorities (RA)
  • Support in managing regulatory questions and ensure that responses are submitted in time
  • Regular follow up with RA and local contact to secure regulatory approval and speed time to market
  • Maintain Local and Global Databases (OPAL, Regulatory trackers...)
  • Initiate Product Sourcing Request (PSR) when required
  • Support in the pack management process for creation, review and approval artwork changes and new pack request
  • Support other regulatory activities to achieve overall objectives when required

Contact information:

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

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