募集要項

仕事内容

●The Manager，Regional Regulatory Hub Strategist is responsible for the below:
●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 Global Chemistry Manufacturing &Controls (GCMC)，Worldwide Safety and Regulatory (WSR)，Global Supply，Submissions Management，PCOs，Labeling，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.
・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 the company commercial strategic planning process as appropriate.
・Co-ordinate with Product Strategist the receipt，distribution and response to regulatory queries from target countries，consistent with departmental procedures and including liaison with Rapid Response Team (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.，Regulatory Requirements database).
・Regularly follow up with PCOs on progress of registration submission and approval activities，and ensure line management are advised of progress in regulatory filings.
・Provide regulatory strategic support by identifying potential regulatory risks，and exploring alternative regulatory strategies to reach outcomes supported by all stakeholders.
・Analyze and view complex scientific data in the context of the external regulatory landscape and incorporate the synthesized information into feasible regulatory strategies.
●Project Management:
・Ensure product strategies，submission and approval timelines，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 in and/or lead cross-functional project teams，to address business needs in line with WSR Emerging Markets business units，Medical Departments，and Country 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.

経験・資格

●資格
・Degree in Science，Pharmacy
・Relevant regulatory experience
・Proven ability to manage complex regulatory or drug development issues.
・Proven ability to consistently deliver to time，cost and quality standards.
・Good 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

勤務地

日本、海外

Recruiting No.

3180_315

企業情報

社名

外資系大手医薬品メーカー

事業内容

医薬品、医薬部外品の製造・販売