Posted on 2021-10-08

Senior Regulatory Affairs Associate

Pfizer Corporation Hong Kong Limited

Why Patients Need You

A career with us is about discovering breakthroughs that change patients’ lives. Pfizer Regulatory Affairs Team plays a key role in coping with the ever-changing local and global regulatory environment. You will be part of a dynamic team to review and interpret the highest standards of regulatory requirements to facilitate the best patient care with strict compliance and integrity. You will help us connect with patients’ journey!

What You Will Achieve

With your expertise in Regulatory Affairs and the support from your mentor and team, you will contribute your expertise to uphold regulatory compliance as well as to develop and execute regulatory strategies. Your professionalism will be demonstrated in a wide range of regulatory initiatives, enabling Pfizer to achieve new milestones and help patients across the globe.

How You Will Achieve It

End-to-end registration activities (pre- and post-approval, withdrawal) for Hong Kong and Macau markets

  • Registration planning with the support and guidance of senior colleagues to obtain intelligence from supporting groups (e.g. RRHS) regarding new product filing, discuss with relevant local stakeholders to confirm local intention of product/SKU choices, source, presentation, desired label etc. as well as develop Risk Management Plan (RMP) in conjunction with local Safety and Medical colleagues and above-country strategists where applicable
  • Perform all necessary procedures relating to regulatory submissions to the Boards of Health
  • Ensure new product submissions are filed with necessary documentation in timely manner aligned with business goals by collaborating with supporting groups (e.g. RRHS, EM PS, HSM, ILG) and stakeholders (including third-party distributor for Macau import license/registration submission)
  • Ensure all Regulatory Affairs related systems, records and relevant processes including Product Event And Registration Licenses system (PEARL), Labelling and artwork updates and their records in Global Document Management System (GDMS), Pfizer Labelling End-to-End Tracking (PfLEET) and electronic Pfizer Artwork and Labelling Management System (ePALMS) as well as RMP and any post-approval commitment tracking are observed and up-to-date
  • Plan and execute communication strategy with the anticipation of stakeholder’s reaction, including but not limited to notify stakeholders registration milestones by Single Channel of Communications (SCC) and effective use of emails as well as interact professionally and effectively with Boards of Health staff for delivering our submission and approval goals
  • Maintain filing plan of assigned portfolio in designated format, communicate to stakeholders periodically and when change, especially when stock continuity is impacted, takes place

Commercial Support

  • Ensure the cited label(s) and regulatory content of promotional materials are up-to-date with registration when requested to be a reviewer
  • Provide regulatory support to business activities e.g. Hospital tenders and quotations
  • Provide support for ad hoc requests, e.g. regulatory information relevant to mitigating supply issue, or named-patient supply

Compliance

  • Ensure compliance to all the required training, applicable regulations, internal standard operating procedures and guidances

Others

  • Serve the team as a subject matter expert of certain area(s)
  • Take part in projects assigned by line manager

  Qualifications

  • Bachelor's Degree in medical or pharmaceutical sciences, life science or related disciplines
  • Minimum 3 years of relevant job experience, e.g. regulatory affairs, research and development or quality assurance/compliance
  • Attention to details
  • Excellent oral and written communication skills
  • Good interpersonal skill
  • Good negotiating skill
  • Highly motivated, mature and a team player

 

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More job information
Salary
Job Function
Industry
Location
  • Quarry Bay
Employment Term
  • Permanent
  • Full-time
Experience
    N/A
Benefits
  • 5-day week
  • 13-month pay
  • Discretionary bonus
  • Insurance plan
  • Medical plan