Job Description

The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for the development and implementation of global strategies, ensuring legislation requirements are met. Provides oversight on strategic regulatory decisions and ensures regulatory and cross-functional alignment. Provides oversight of development of impactful strategic messaging in regulatory dossier content. Exercises division and corporate influence, provides expert opinion and leadership to initiatives. When delegated by the TA VP, provides regulatory leadership at the Therapeutic Area Strategy Committee (TASC) to deliver TA strategies, disease state insights, vision and direction to differentiate assets regulatory strategic program risks, regulatory intelligence, and recommendations on portfolio optimization. Has department leadership and budgetary accountabilities

Responsibilities

Provides leadership and supervision to a team of global regulatory leads (GRLs) who are responsible for developing and implementing regulatory strategy for development and marketed products. Key internal leader and driver of regulatory policy and strategy; ensures development of creative and impactful global product strategies for each product.

Works to develop and achieve long-range goals and objectives. Determines and pursue courses of action necessary to obtain desired results. Provides guidance to GRL on global regulatory strategies, risk assessments and mitigation strategies. Approves global regulatory product strategies and risk assessments with mitigation plans for products within assigned TAs.

Supervises GRL personnel. Independently manages product and project assignments within TA, and may participate or lead initiatives. Provides direction and guidance to adjacent regulatory personnel; evaluates performance of and assists in career development planning for other regulatory functions

Works across TAs for assigned products and influences the development of regulations and guidance

Advises internal personnel on regulatory strategies. Provides expert assessment on disease state insights, vision, and direction to differentiate assets, regulatory intelligence on global regulatory environment, and provides recommendations to TASC and Sr. Management to optimize portfolio.

Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures regular regulatory management communication of important timely issues and the impact on the global program and across assigned TA.

Develops, communicates, and builds consensus for operating goals that are in alignment with the department. Oversees personnel to achieve department objectives. Ensures creation of immediate to long-range plans to carry out objectives established by executive management. Provides guidance and recommendations to direct reports on work processes and operational plan decision-making.

Advances the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for TA. Represents Regulatory and presents to cross-functional teams as TA Lead. Represents Regulatory on other AbbVie governance and review committees at the request of the TA VP.

Develops and maintains budget for a department or group to meet organizational goals. Forecasts future departmental needs including human and material resources and capital expenditures. Actively participates in leadership meetings, providing regulatory and management expertise and decision-making. Recommend modifications to the structure of organizational units or a centralized functional activity subject to senior management approval.