Regulatory Affairs Specialist

4 weeks ago


Hong Kong, Central and Western District, Hong Kong SAR China Pfizer Full time

Pfizer is a global leader in the pharmaceutical industry, dedicated to delivering innovative medicines that improve lives.

Job Overview

We are seeking a highly skilled Regulatory Affairs Associate to join our team. This role will be based at one of our locations worldwide and will provide support to our regulatory affairs team.

Key Responsibilities
  • Manage an efficient documentation system, record retention, and information services in compliance with regulatory requirements.
  • Ensure procedures are in place to maintain records and interpret all documentation standards, policies, and operating procedure requirements.
  • Identify submission components, communicate documentation standards, and coordinate assembly of regulatory dossiers.
  • Maintain knowledge of product information and continuous contacts with local, regional, and divisional customers.
Requirements
  • Bachelor's Degree in a relevant field.
  • Proven ability to speak to large groups of people to provide system and process flow training.
  • Maintains familiarity with company product ranges and ensuring 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, etc.
Benefits

We offer a competitive salary of approximately $65,000 per year, depending on experience and location. Our benefits package includes health insurance, retirement plans, and paid time off.

We are an equal opportunity employer and comply with all applicable equal employment opportunity legislation in each jurisdiction in which we operate.



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