Regulatory Affairs Specialist

3 weeks ago

Singapur, Singapore Baxter Full time
About the Role

Baxter is a leading global healthcare company that is deeply connected by its mission to save and sustain lives. As a Senior Specialist, Regulatory Affairs, you will play a critical role in ensuring the company's products and therapies meet the highest regulatory standards.

Key Responsibilities
  • Develop and execute regulatory project plans to ensure compliance with international regulatory requirements.
  • Identify and elevate key areas of regulatory risk to ensure the company's products and therapies are safe and effective.
  • Maintain current knowledge of international regulatory requirements, guidance, and standards applicable to company products.
  • Participate as an active team member and provide regulatory advice to project teams as required.
  • Respond to questions from regulatory authorities within strict timelines.
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements.
  • Maintain and update existing regulatory authorizations.
  • Support regulatory activities relating to specific portfolio of products/projects.
  • Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations.
  • Prepare SOPs to reflect specific local requirements.
  • Review advertisement and promotional literature when needed.
  • Represent or lead Regulatory Affairs in small project teams.
  • Provide guidance to junior team members when needed.
  • Perform other duties as assigned.
  • Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
Work Knowledge / Skills Required
  • Well-versed with new registration, license extensions, variations, and renewals. Experience with Class II devices onwards is mandatory.
  • Knowledge of applicable regulatory laws and acts and well-versed with changing scope and evolving regulations.
  • Good understanding of GDPMD.
  • Project management skills.
  • Manage multiple projects and deadlines.
  • Ability to multitask and prioritize.
  • Interpersonal and communication skills.
  • Negotiation skills.
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research).
  • Ability to identify compliance risks and escalate when necessary.

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