Our client, a multinational Pharmaceutical company, is seeking to recruit for a Project Regulatory Executive. You will be directly reporting to the Senior Country Strategist Or Regulatory Country Head



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.

• Single point of contact for AFME team on regional optionality issues.

• 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 Company’s commercial strategic planning process as appropriate.

• Manage customization and dispatch dossiers to PCOs.

• 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 with PCOs on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.



Project Management:

• Oversee and/or facilitate training of Optionality project, including improvements to processes and procedures, systems and databases, and applicable Company’s policies and procedures.

• Ensure product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.

• Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.

• Participate and/or lead cross-functional project teams, to address business needs in line with Project objectives for business units, Medical Departments, and County business objectives.

• Represent their countries at relevant regulatory and project teams, or interdivisional meetings, as appropriate

• Ensure that comprehensive records of communications, country requirements and regulatory status, are maintained.

• To regularly follow up progress on regulatory submissions with PCO countries.

• Contributes to the development of filing and approval goals for the region.

• Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.

Job Details

Preferred Candidate

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