Why Patients Need You
The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.
What You Will Achieve
Reliable documentation services form an essential component of a well-run Regulatory Affairs department. You will be the one entrusted with managing an efficient documentation system, record retention, and information services in compliance with regulatory requirements. You will ensure that 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 assembly of regulatory dossiers. You will maintain knowledge of product information and continuous contacts with local, regional, and divisional customers.
Want more jobs like this?
Get Business Operations jobs in Hong Kong delivered to your inbox every week.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your dedication and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contribute to the completion of project milestones and organize own work to meet project task deadlines.
- Provide regulatory insight & strategies to cross function team as regulatory liaison throughout the product lifecycle.
- Prepare, submit, coordinate and follow up on product registrations to ensure timely approval according to 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 Regulatory Affairs team lead to establish, develop and maintain close working relationships with the 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 the 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 Pharmaceutical industry
- Prior knowledge of local regulatory environment and regulations
- Knowledge of effective training methods
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
#LI-PFE