Regulatory Affairs Specialist

1 week ago

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

Pfizer's Regulatory Affairs team plays a critical role in ensuring the company's products meet regulatory requirements. As a Regulatory Affairs Associate, you will be part of a dynamic team that reviews and interprets regulatory requirements to facilitate the best patient care.

What You Will Achieve

You will be responsible for managing an efficient documentation system, record retention, and information services in compliance with regulatory requirements. This includes ensuring procedures are in place to maintain records and interpret all documentation standards, policies, and operating procedure requirements.

You will identify submission components, communicate documentation standards, and coordinate the assembly of regulatory dossiers. You will maintain knowledge of product information and continuous contacts with local, regional, and divisional customers.

How You Will Achieve It
  • 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 the product registration plan and handle any amendments to registered products.
  • Provide regulatory affairs-related information to other divisions and coordinate regulatory activities between divisions, Business Units, Corporate Affairs, Quality Operations, etc.
  • 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 and ensure compliance with other relevant company SOPs.
  • Responsible for the periodic review of all documents and procedures, ensuring the required due dates are consistently met, preserving document integrity.
  • Provide supporting documents for government/Hospital Authority tender applications.
  • Maintain relevant registration licenses, regulatory affairs-related information/system, correspondence, and other relevant documentation for easy retrieval.
Qualifications

Must-Have

  • Bachelor's Degree
  • 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.

Nice-to-Have

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

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