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Regulatory Project Associate
hace 2 semanas
We're committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your contributions will ensure that our products meet the highest standards of regulatory compliance, ultimately helping patients receive the treatments they need more efficiently.
Job Summary
- Regulatory Project Associate role provides both operational and coordination support to the GRS-RIO-EM organization.
- As needed, will also support with special projects (in-country, regional, regulatory initiatives within the organization)
Job Responsibilities
Regulatory Coordination Support
- Preparation and management of relevant monthly reports and communications.
- Analytical and operational related support for related systems/processes (including SPA reporting, RRM maintenance, CST requests, Veeva, product milestone and departmental metrics tracking, Reliability Performance, Reg21, etc.)
- Ensure that regulatory documentation meets relevant regulatory requirements.
- Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
- Support any special project as requested by manager or support departments managers/designee.
- Knowledge and understanding of quality systems, processes, audit and inspections.
- Ability to influence at all levels in the organization and build networks internal and externally.
General Support
- Provide a full range of operational support to the GRS-EM-RIO Organization.
- Ensure regular liaison with department managers to assess workload and priority activities.
- Make arrangements and coordinate meeting/conference/training activities to ensure information on venue, time and people is communicated in advance.
- Prepare and distribute minutes of meetings when required.
- Organize travel arrangements for teams/visitors (Pfizer colleagues from overseas) as required.
- Liaise with the travel agency or manage Pfizer global booking system (e.g. PT&E) to arrange air tickets, itinerary and book accommodation.
- Obtain requirements for the trip - equipment, visa, travel approvals and travelers cheque.
- Assist Departments in creating or raise purchase orders electronically for goods and services.
- Generate quotations and purchase orders.
- Ensure the payment of all invoices in a timely manner.
Qualifications / Skills
- Degree in Business Administration or related discipline.
- +3 years of experience in administrative/operational role.
- Working experience in a regulatory affairs environment.
- Fluent in English – written and spoken communication skills.
- Meticulous nature and proficient in data tracking and consolidation.
- Ability to work independently and as part of a team.
- Proven ability to consistently deliver to time, cost and quality standards.
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs
