【非公開求人】【薬事】薬事戦略と市場アクセスを担うアソシエイトマネージャー｜外資系企業｜東京｜正社員

Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature ?? Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.) Assists in the development of regulatory strategy and updates strategy based upon regulatory changes Evaluates proposed products for regulatory classification and jurisdiction Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization? Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes Negotiates with regulatory authorities throughout the product lifecycle Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Assists other departments in the development of SOPs to ensure regulatory compliance Provides regulatory input and technical guidance on global regulatory requirements to product development teams Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process Provides regulatory information and guidance for proposed product claims/labeling Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines Monitors the progress of the regulatory authority review process through appropriate communications with the agency Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

【必須要件】 ・Typically a minimum of 6 years’ experience ・MS or RAC(s) preferred

完全週休2日制（土・日）、祝日、夏期（3日）、年末年始（7日）、特別休暇 ※年間休日数　124日

育児休業制度、育児短時間時間勤務制度、介護休業制度、退職金制度、財形貯蓄制度、借上社宅制度、団体生命保険制度、リロクラブ福利厚生制度