Reliable documentation services are crucial for a well-run Regulatory Affairs department. You will manage an efficient documentation system, record retention, and information services in compliance with regulatory requirements. You will ensure procedures are in place to maintain records, interpret documentation standards, policies, and operating procedure requirements. You will identify submission components, communicate documentation standards, and coordinate the assembly of regulatory dossiers. Maintaining knowledge of product information and continuous contact with local, regional, and divisional customers will be part of your role.
Responsibilities
- Contribute to the completion of project milestones and organize own work to meet project task deadlines.
- Provide regulatory insight and strategies to cross-functional teams as a regulatory liaison throughout the product lifecycle.
- Prepare, submit, coordinate, and follow up on product registrations to ensure timely approval according to the 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 the Regulatory Affairs team lead in establishing, developing, and maintaining close working relationships with relevant regulatory authorities and associations.
- Follow necessary approval procedures in updating Local Product Documents 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 due dates are consistently met, preserving document integrity.
- Provide supporting documents for 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
- 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 the Pharmaceutical industry
- Prior knowledge of the local regulatory environment and regulations
- Knowledge of effective training methods
