Senior Manager, Regulatory Affairs Quality Assurance (RAQA), Mexico

What you will do -

• Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy. Participates in advocacy activities of a more advanced strategic nature. Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies. Provides guidance to integrate regulatory considerations into global product entry and exit strategy. Identifies regulatory pathways for initial product designs and provides input to internal stakeholders. Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.
• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles. Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations. Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy). Negotiates with regulatory authorities on complex issues throughout the product lifecycle. Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures. Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance. Provides strategic input and technical guidance on global regulatory requirements to product development terms. Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions. Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans. Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases. Provides regulatory guidance on strategy for proposed product claims/labeling.
• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims. Manages electronic (eCTD) and paper registration development. Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions. Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process. Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees.
• Manage day-to-day regulatory processes to ensure issues are appropriately evaluated. Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement. Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met. Serve as Subject Matter Expert for regulatory processes.
• Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations. Establish standard process to ensure appropriate resolution and management of the responsible task owner. Chair meetings required to drive closure of regulatory issues. Manage and provide updates for regulatory metrics. Implement appropriate enhancements. Represent regulatory processes during internal and external audits.
• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets. Recruit, select, and on-board top talent. Develop talent within team to increase performance. Actively address performance issues on team. Maintain a high level of team engagement. Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature.

What you need –

• Bachelor's degree required, in a science, engineering or related Advanced degree preferred.
• 10+ years of experience required.
• People management experience required.
• Fluency in English and Spanish required.
• Master's Degree or equivalent preferred.
• RAC (Regulatory Affairs Certification) preferred.