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Regulatory Compliance Specialist

2 months ago


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

Importance of Your Role

In a landscape of evolving regulations, Pfizer requires a proficient Regulatory Affairs team. You will contribute to a proactive group that assesses and interprets the growing regulatory landscape and its associated commercial implications to ensure optimal patient care. Our patients rely on dedicated professionals like you, who prioritize their well-being and possess expertise in the field.

Key Responsibilities

Efficient documentation practices are vital for a successful Regulatory Affairs department. You will be responsible for overseeing a streamlined documentation system, record retention, and information services that comply with regulatory standards. Your role will involve ensuring that processes are established to maintain records and interpret all documentation standards, policies, and operational requirements. You will identify submission components, communicate documentation standards, and coordinate the assembly of regulatory submissions. Staying informed about product information and maintaining ongoing communication with local, regional, and divisional stakeholders will be essential.

As an associate, your commitment to your responsibilities will play a crucial role in achieving project objectives. Your expertise and dedication will foster a collaborative environment for your colleagues.

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

How You Will Contribute

Assist in meeting project milestones and organize your work to adhere to project deadlines. Provide regulatory insights and strategies to cross-functional teams as a regulatory liaison throughout the product lifecycle. Prepare, submit, coordinate, and monitor product registrations to ensure timely approvals in line with the registration plan and manage any amendments to registered products. Share regulatory affairs-related information with other divisions and coordinate regulatory activities across divisions, Business Units, Corporate Affairs, Quality Operations, etc. Support the Regulatory Affairs team lead in establishing and nurturing relationships with relevant regulatory authorities and associations. Follow necessary procedures for updating Local Product Documents in accordance with local regulatory requirements and Pfizer's Standard Operating Procedures (SOPs). Ensure that registered products are maintained and updated in full compliance with all applicable legislation and SOPs, while also ensuring adherence to other relevant company SOPs. Conduct periodic reviews of all documents and procedures, ensuring that due dates are consistently met and document integrity is preserved. Provide necessary documentation for government and Hospital Authority tender applications. Maintain relevant registration licenses, regulatory affairs-related information, correspondence, and other documentation for easy access.

Required Qualifications

Essential Skills

Bachelor's Degree Proven ability to deliver presentations to large groups regarding system and process training Familiarity with company product ranges and ensuring adherence to regulations Strong knowledge of electronic repositories and 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 in Clinical Trial Applications (CTA) Demonstrated experience in the Pharmaceutical industry Prior knowledge of local regulatory environments and regulations Understanding of effective training methodologies

Pfizer is an equal opportunity employer and adheres to all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs#LI-PFE