Our Client a leading Pharma company is looking for a Regulatory Affairs Specialist.
This is a contract role under ManpowerGroup - 12 months renewable
• Reports to AfME Regulatory Affairs Strategist
Position Purpose
• To manage projects and product-related registration strategies in the assigned countries.
• Single point of contact on regional issues
• To ensure that regulatory documentation meet relevant regulatory requirements.
• To apply knowledge and interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation 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 Product Strategists and Regulatory staff.
• To build local relationships and ensure communication/clarity of regulatory timelines and strategy
Primary Responsibilities
Regulatory:
• Apply regulatory expertise for assigned therapeutic categories/countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
• Provide input to the regulatory strategy for the development of products 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.
• Liaise with key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
• Support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
Primary Responsibilities
• Manage regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
• Provide input to the local/regional commercial strategic planning process as appropriate.
• Co-ordinate with Product Strategist the receipt, distribution and response to regulatory queries from target countries, in line with product role, consistent with departmental procedures and including liaison with members to ensure that response targets are met.
• Manage customization and dispatch dossiers.
• Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure regulatory requirements (e.g., department presentations and Regulatory Requirements Database) and assist with assessing the regulatory environment and identifying relevant trends.
• Regularly follow up 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 activity, including improvements to departmental processes and procedures, systems and databases, and applicable 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 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 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
| Posted Date: | 2018-11-04 |
| Job Location: | Dubai, United Arab Emirates |
| Job Role: | Administration |
| Company Industry: | Employment Placement Agencies/Recruiting |
Preferred Candidate
| Career Level: | Mid Career |
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