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Regulatory Compliance Specialist

2 months ago

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

Why This Role Matters

In a landscape of evolving regulations, Pfizer recognizes the importance of a proficient Regulatory Affairs team. As a member of this vibrant group, you will engage in the assessment and interpretation of growing regulatory demands and their commercial implications, all while prioritizing optimal patient care. Your expertise will be vital in ensuring that our patients receive the highest standard of care through diligent regulatory practices.

Key Responsibilities

Effective documentation management is crucial for a successful Regulatory Affairs department. You will oversee the organization of documentation systems, ensure compliance with retention policies, and provide essential information services. Your role will involve establishing procedures for record maintenance and interpreting documentation standards, policies, and operational requirements. You will identify components necessary for submissions, communicate documentation standards, and coordinate the assembly of regulatory submissions. Maintaining up-to-date knowledge of product information and fostering continuous communication with local, regional, and divisional stakeholders will be essential.

As an associate, your contributions will be instrumental in meeting project objectives and deadlines. Your expertise and dedication will foster a collaborative environment among your colleagues.

Your commitment will empower Pfizer to reach new achievements and support patients worldwide.

How You Will Contribute

Assist in achieving project milestones and manage your tasks to adhere to deadlines. Provide regulatory insights and strategies as a liaison throughout the product lifecycle. Prepare, submit, and coordinate product registrations to ensure timely approvals and manage amendments. Share regulatory information with other divisions and facilitate regulatory activities across departments. Support the Regulatory Affairs team lead in building and maintaining relationships with relevant regulatory bodies. Follow approval protocols for updating Local Product Documents in line with regulatory standards. Ensure compliance of registered products with legislation and internal SOPs, maintaining document integrity. Conduct periodic reviews of documents and procedures to meet due dates. Provide necessary documentation for government and hospital authority applications. Maintain relevant licenses and regulatory 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 and Adobe Acrobat

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 in which it operates.

Regulatory Affairs#LI-PFE