Regulatory Affairs Specialist

2 months ago

Hong Kong, Central and Western District, Hong Kong SAR China Pfizer Full time
Why Patients Need You

Pfizer's dynamic regulatory environment demands a skilled and knowledgeable team to navigate the complexities of regulatory requirements and commercial pressures. As a Regulatory Affairs Associate, you will be part of a collaborative team that prioritizes patient well-being and ensures compliance with regulatory standards.

What You Will Achieve

As a key member of the Regulatory Affairs team, you will be responsible for managing documentation services, record retention, and information systems. Your expertise will ensure that procedures are in place to maintain records and interpret documentation standards, policies, and operating procedure requirements.

Key Responsibilities
  • Contribute to the completion of project milestones and organize your work to meet project task deadlines.
  • Provide regulatory insight and strategies to cross-functional teams as a regulatory liaison throughout the product lifecycle.
  • Prepare, submit, coordinate, and follow up on product registrations to ensure timely approval according to product registration plans.
  • Provide regulatory affairs-related information to other divisions and coordinate regulatory activities between divisions, business units, corporate affairs, quality operations, and other stakeholders.
  • Assist the Regulatory Affairs team lead in establishing, developing, and maintaining close working relationships with relevant regulatory authorities and associations.
  • Follow necessary approval procedures in updating local product documents as per local regulatory requirements and Pfizer's Standard Operating Procedures (SOPs).
  • Ensure that registered products are maintained and updated in full compliance with all relevant legislation and SOPs.
  • Responsible for the periodic review of all documents and procedures, ensuring required due dates are consistently met and preserving document integrity.
  • Provide supporting documents for government and hospital authority tender applications.
  • Maintain relevant registration licenses, regulatory affairs-related information, systems, correspondence, and other relevant documentation for easy retrieval.
Qualifications

Must-Have

  • Bachelor's Degree
  • Proven ability to communicate complex information to large groups of people
  • Maintains familiarity with company product ranges and ensures compliance with regulations
  • Robust knowledge of electronic repositories and document management systems
  • Good interpersonal, communication, and negotiation skills
  • Fluency in written and spoken English
  • Excellent computer skills in Microsoft Office Suite, Adobe Acrobat, and other relevant software

Nice-to-Have

  • Experience in Clinical Trial Application (CTA)
  • Demonstrated experience in the pharmaceutical industry
  • Prior knowledge of local regulatory environments and regulations
  • Knowledge of effective training methods

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