Regional Regulatory Hub Strategist

Job description / Role

Our Client is looking for a Regional Regulatory Hub Strategist. 

This is a 12 months renewable contract role under Manpower ME

Organizational Relationship
• 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).
• 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 company’s 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 ISR, 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 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 WSR EM business units, Medical Departments, and County business objectives.
• Represent their countries at relevant regulatory and project teams, or inter divisional 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.

Requirements

• Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
• Appropriate Regulatory Experience – minimum 3-5 years experience
• Proven ability to manage complex regulatory or drug development issues.
• Proven ability to consistently deliver to time, cost and quality standards.
• Fluent in English – written and spoken communication skills
• Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
• History of delivery – country and/or regional
• Country/regional knowledge (specifically, MER, NEAR, South Africa, Maghreb)

About the Company

We lead in the creation and delivery of innovative workforce solutions and services that enable our clients to win in the changing world of work.

ManpowerGroup powers the success of many of the world's most dynamic organizations. We deliver innovative workforce solutions that enhance competitiveness, increase efficiency and spur productivity. Combining global reach with local expertise - 3600 offices in over 80 countries - we know the changing world of work and bring a deep understanding of the companies we work for and the industries we service.

ManpowerGroup entered the Middle East in December 2007 after acquiring local company Clarendon Parker, thus bringing 15 years in-depth local knowledge combined with a global footprint and industry shaping expertise and thought leadership. Manpower Middle East supports clients in the Middle East and North Africa regions. Our business is aligned to key skill specializations to ensure our clients requirements are met by expert and knowledgeable consultants that understand your industry and role requirement.

Our consultants are experts in finding the right talent across all industries in a broad-range of occupations including:

• IT & Telecommunications
• Engineering & Construction, Oil & Gas
• Banking, Finance & Legal
• Sales & Business Development
• Marketing, Public Relations & Communications
• Human Resources & Training
• Customer & Support Services (Secretarial and Administrative)
• Operational, Supply Chain & Logistics
• Executive Recruitment
• Emiratization Solutions
• Recruitment Program Outsourcing Solutions
• Managed Service Provider Solutions
• Talent Based Outsourcing Solutions
• Outsourced Staffing Solutions