Our client, a multinational Pharmaceutical company, is seeking to recruit for a Project Regulatory Coordinator. You will be directly reporting to the Senior Optionality Strategist OR Country Regional Regulatory Lead



This is a contracting staffing role under Manpower for a contract period of 12 months (Renewable depending on company requirements and/or individual performance).



Position Purpose

• Business Critical

• To manage the Optionality project and product-related registration strategies in the assigned countries.

• Analysis and categorization of AFME licenses

• Assessment of applications currently ongoing within markets for each license

• Assessment with the BU regarding revenues.

• Assessment of parallel LENC projects impacting Optionality process within Region.

• Assessment of packaging requirements and implications thereof on the project.

• To ensure that regulatory documentation meet relevant regulatory requirements.

• To apply knowledge and interpretation of regulatory requirements in the assigned countries to the Optionality project and process, including requirements of health authority marketing authorization dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.

• To ensure business continuity between headquarter stakeholders and Regulatory PCO staff.

Primary Responsibilities



Regulatory:

• Apply regulatory expertise for assigned countries to enable preparation of high quality documentation and assure compliance with departmental procedures.

• Provide input to the regulatory strategy for the project in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply)and alignment is achieved between regulatory activities and relevant country business/commercial plans.

• Maintain AFME Optionality Tracker

• Manage regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.

• Provide input to the local/regional Pfizer commercial strategic planning process as appropriate.

• Manage customization and dispatch dossiers .

• Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that all relevant stakeholders are aware of regulatory requirements for Optionality project.

• Regularly follow up the progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.

Job Details

Preferred Candidate

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