Regulatory Compliance Specialist

7 days ago

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

Importance of Your Role

In a constantly evolving regulatory landscape, Pfizer relies on a proficient Regulatory Affairs team. As a key member of this dynamic group, you will analyze and interpret the growing regulatory demands alongside their commercial implications to ensure optimal patient care. Your expertise will be vital in prioritizing the well-being of our patients.

Key Responsibilities

Efficient documentation practices are crucial for a successful Regulatory Affairs department. You will be responsible for overseeing a robust documentation system, ensuring compliance with regulatory standards and maintaining proper record retention. Your role will involve identifying submission elements, communicating documentation protocols, and coordinating the assembly of regulatory submissions. You will also keep abreast of product information and maintain ongoing communication with local, regional, and divisional stakeholders.

As an associate, your dedication will significantly contribute to achieving project objectives. Your expertise and commitment will foster a collaborative environment for your colleagues.

Your focus and dedication will empower Pfizer to reach new milestones and support patients worldwide.

How You Will Contribute

Assist in meeting project milestones and organize your tasks to adhere to deadlines. Provide regulatory insights and strategies as a liaison throughout the product lifecycle. Prepare, submit, and manage product registrations to ensure timely approvals in line with registration plans, addressing any amendments as necessary. Share regulatory information with other divisions and coordinate activities across Business Units, Corporate Affairs, and Quality Operations. Support the Regulatory Affairs team lead in building and maintaining strong relationships with relevant regulatory authorities and associations. Follow the required procedures for updating Local Product Documents in accordance with local regulations and Pfizer's Standard Operating Procedures (SOPs). Ensure that registered products remain compliant with all applicable legislation and company SOPs. Conduct periodic reviews of documents and procedures to ensure compliance with due dates and maintain document integrity. Provide necessary documentation for government and Hospital Authority tender applications. Maintain relevant licenses, regulatory information, and documentation for efficient retrieval.

Required Qualifications

Essential Skills

Bachelor's Degree Proven ability to deliver training to large groups on systems and processes Familiarity with company product lines and regulatory compliance Strong knowledge of electronic document management systems Excellent interpersonal, communication, and negotiation skills Proficiency in written and spoken English Advanced computer skills in Microsoft Office Suite, Adobe Acrobat, etc.

Preferred Qualifications

Experience with Clinical Trial Applications (CTA) Background in the Pharmaceutical industry Understanding of local regulatory frameworks Knowledge of effective training methodologies

Pfizer is committed to equal opportunity employment and adheres to all applicable equal employment opportunity laws in every jurisdiction where it operates.

Regulatory Affairs#LI-PFE

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