Sr. Director, Regulatory Affairs Strategy – Facial Aesthetics, Pharma

The Sr. Director Regulatory Affairs Pharmaceuticals is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams.  Communicates regulatory strategy to project teams developing biologic and combination products. Leads a global team of regulatory professionals to ensure successful planning and completion of regulatory activities on a worldwide basis.  Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) with responsibility for working with colleagues on a worldwide basis to form a global strategy.  Responsible for content of global regulatory submissions.  Directs communications and interactions with US FDA and other regulatory agencies worldwide.  Responsible for covering multiple development projects.

Advisory Responsibilities:

• Support team with presentations to Governance Boards and other Senior Leadership meetings. Closely liaise with Regulatory therapeutics team to ensure consistency in strategy and alignment within Regulatory Aesthetics. Develops regulatory strategic plan and provides guidance to project team to enable accelerated options for enterprise critical projects. Works with project team to resolve complex project issues.  Utilizes significant regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.

Submissions:

• Able to navigate complexity of and supports product registrations for BLA, MAA etc. based on extensive experience.  Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions. Assists team to increase their knowledge of the pharma/ biologics regulatory framework. Ensures compliance with project team timelines and milestones.

Communications:

• Able to clearly articulate regulatory strategy at senior leadership and governance meetings.  Mentors team members to build their negotiation and strategic thinking skills within the project team and externally with health authorities.  

Health Authority Interactions:

• Directly interact with global health authorities and/ or advise teams for meetings with regulatory agencies.  Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Provide guidance to regulatory team members to strengthen their ability to respond to and anticipate regulatory health authority actions. Able to interpret agency actions to navigate potentially complex jurisdictional situations to facilitate a successful outcome.

Team Development

• Extensive global team leadership and development in a hybrid/ virtual environment to support 6-8 direct reports. Performance management and goal setting. Management of team budget and resources.

• PhD, or PharmD degree or equivalent in a scientific field, plus at least 10 years’ experience in Regulatory Affairs with at least 3 years of management of a 6-8 person regulatory team
• MS degree or equivalent in a scientific field, plus at least 12 years’ experience in Regulatory Affairs with at least 3 years of management of a 6-8 person regulatory team
• BS degree or equivalent in a scientific field, plus at least 15 years’ experience in Regulatory Affairs at least 3 years of management of a 6-8 person regulatory team
• Demonstrated excellence in developing global regulatory affairs strategy.
• Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance as regulatory lead on global project teams
• Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience, direct Agency experience a plus
• Excellent interpersonal skills
• Exceptional communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations
• Experience working in a matrixed environment 
• Ability to work independently
• Ability to travel for up to 20% (to include International Travel)

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.