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    Senior Specialist, Regulatory Affairs - Petaling Jaya, Malaysia - Baxter

    Baxter
    Baxter Petaling Jaya, Malaysia

    Found in: Talent MY C2 - 3 days ago

    Default job background
    Full time
    Description

    This is where you save and sustain lives

    At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

    Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

    Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

    Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

    Role Summary:

  • Under limited supervision responsible for the local implementation of regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of Baxter's products. Support regulatory and quality activities relating to specific portfolio of products/projects.

    • Essential Duties & Responsibilities:

    Regulatory Affairs

  • Experienced in drugs, biologics and medical devices.
  • With direction, develop and execute regulatory project plans.
  • Identify and elevate key areas of regulatory risk.
  • Maintain awareness of regulatory requirements; identify relevant requirements.
  • 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.
  • Represent or lead Regulatory Affairs in small project teams.
  • Provide guidance to junior team members when needed.
  • Perform other duties as assigned.

    • Quality Assurance

  • Appoint as designated person /QMR for GDPMD.
  • Responsible for product complaint related matter/non-conformances/product recalls/FAs and ensure procedure compliance.
  • Responsible for the completion of Product Complaint reporting to ensure notification to Complaint Coordinator within required timeframe and investigation of returned samples to determine root cause.
  • Immediate follow-up of potential Medical or Adverse Event product complaints according to corporate requirements.
  • Report, follow-up and trend product complaints.
  • Responsible for FA related actions viz. customer notification letters, regulatory reporting and product recall activities.
  • Reply to customer complaint, queries related to quality, presentation to customer on quality.
  • Responsible for release of Finished Goods with temperature controlled and after routine redressing.
  • Responsible for redressing instruction.
  • Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
  • Oversee documentation to ensure completion of records and GDP Compliance.
  • Prepares SOP, Document Change Request (DCRs) and Periodic Review.
  • Ensure compliance with SOPs, quality assurance, internal and local regulations and GDPMDS (GDP for Medical Devices) standards.
  • Responsible for managing suppliers with the support of supplier quality function.
  • Assist with data gathering and analysis for Quality Reviews/Complaint to ensure occurs at required frequency.

    • Education & Experience:

  • Degree in Pharmacy, Science or related discipline is an advantage.
  • At least 3 years of relevant experience in medical devices, pharmaceutical and biologics.
  • Regulatory and quality experience (within a healthcare environment.
  • Well-versed with new registration, license extensions, variations and renewals. Experience with both drugs and medical device registration is an advantage.
  • Knowledge of applicable regulatory laws and acts and well-versed with changing scope and evolving regulations.
  • Knowledge of regulations 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.

    • Reasonable Accommodations

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