What you will do -Assess links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.
Participate in advocacy activities of a more advanced strategic nature.
Develop and update global, regional and multi-country regulatory strategy, and align regulatory strategies to organizational strategies.
Provide guidance to integrate regulatory considerations into global product entry and exit strategy.
Identify regulatory pathways for initial product designs and provide input to internal stakeholders.
Analyze the adequacy of proposed regulatory pathways and strategy for initial product designs and recommend changes or refinements based on initial regulatory outcomes.Assess all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.)
and develop solutions to address anticipated obstacles.
Critically assess the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.
Provide 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).
Negotiate with regulatory authorities on complex issues throughout the product lifecycle.
Establish working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.Identify the need for and manage the development and execution of new regulatory procedures and standard operating procedures.
Develop and manage programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Provide strategic input and technical guidance on global regulatory requirements to product development teams.
Evaluate risks of product and clinical safety issues during clinical phases and recommend regulatory solutions.Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans for changes that do not require submissions.
Review and assess proposals to regulatory authorities on regulatory paths and clinical plans.
Monitor implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
Provide regulatory guidance on strategy for proposed product claims/labeling.Ensure clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
Manage electronic (eCTD) and paper registration development.
Ensure policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
Lead key negotiations and interactions with regulatory authorities during all stages of the development and review process.
Prepare 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 onboard top talent.
Develop talent within team to increase performance.
Actively address performance issues on team.
Maintain a high level of team engagement.
Participate 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 field.
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.
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