Develops strategies for earliest possible approvals of drug applications and device registrations. Ensures appropriate project/program Regulatory support. Participates in higher level interactions with external partners. Formulates corporate responses to regulatory agencies and pharmaceutical group initiatives. Functions as primary senior regulatory representative for negotiations with US and ex-US regulatory agencies. Interacts with senior level regulatory personnel at partner companies and contract manufacturers. May select, develop, and evaluate personnel to ensure the efficient operation of the function.
Develops corporate and/or organizational policies and authorizes their implementation. Consistently works with abstract ideas or situations across functional areas of the business. Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters. Coordinates and ensures internal/external resources are appropriate to ensure quality and timeliness of global regulatory submissions. Assists in the selection and early development of programs by developing regulatory strategies and identifying regulatory risks. Forecasts future staffing requirements. Responsible for ensuring Regulatory Affairs has resources (staffing and facilities) to maintain documentation. Ensures internal and/or external resources are adequate to provide Regulatory Affairs support for company projects. Interacts with (senior level) regulatory personnel at partner companies, contract manufacturers and regulatory agencies. Ensure resources are identified to support short- and long-term corporate goals, and communicates impacts to Project Management/Managers and senior management. Functions as senior contact for negotiations and interactions with US and ex-US regulatory agencies for internal programs. Interacts with internal and external executive management requiring skillful negotiations of complex matters to influence policy-making bodies. Evaluates industry organizations and governmental agency initiatives and prepares company responses. Resolves significant conflicts and disputes within and/or across departments. Negotiates win/win scenarios for organizational productivity and efficiency. Reviews and manages overall departmental activities, ensuring alignment with company project timelines. Manages departmental budget to plan, communicating major deviations and impacts to senior management. Forecasts the most efficient use of internal and external staffing resources to ensure appropriate program/project regulatory support. Provides input to R&D department activities, including but not limited to; Regulatory Affairs staffing requirements, budget proposal and tracking, regulatory SOPs, training requirements, documentation retention policy and implementation, and etc. Provides regulatory opinion, reflecting Regulatory Affairs department practice/philosophy/policy to executive management. May be responsible for conducting performance reviews and providing feedback and coaching to direct reports.