We are now recruiting for a Regional Regulatory Hub Strategist
This is a Contract Role under ManpowerGroup ME. It's a 12 months renewable contract.
Organizational Relationship(s) including to whom the position reports (JD Job Title):
Reports to Director/Regional Regulatory Hub Team Lead
Close collaboration with WSR-EM above country and PCO staff
Partners with relevant functional teams, including GCMC, Commercial, Submission, labeling, Business and Development, PGM, and WRD (regional and global, where needed).
Position Purpose
To manage projects and product-related registration strategies in the assigned countries.
Single point of contact for WSR-EM and PCO team 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 headquarter Product Strategists and Regulatory PCO 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 WSR-EM 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 GCMC, WSR, PGS, Submissions Management, PCOs, ILG, ALIM, Cluster/Market, and any other 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.
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 in WSR, consistent with departmental procedures and including liaison with RRT members to ensure that response targets are met.
Manage customization and dispatch dossiers to PCOs.
Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that WSR-EM is aware of regulatory requirements (e.g., department presentations and Regulatory Requirements Database) and assist WSR EM Policy with assessing the regulatory environment and identifying relevant trends.
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 Hub activity, including improvements to WSR EM departmental processes and procedures, RRS curriculum, WSR 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 WSR EM 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
| Posted Date: | 2018-10-01 |
| 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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