The Associate Director of Regulatory Affairs – Pharma supports regulatory objectives for the company’s facial aesthetics pharma products including coordination, management of global submissions. Directs and supports development of the regulatory strategy and submission activities for pharma regulatory approvals in a variety of counties including EU, US, Japan, and China. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan Aesthetics at Regulatory Authority meetings as well as industry meetings. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all company policies and procedures.

Responsibilities include:

• Leads and/or supports pharma development and global filing activities from a regulatory standpoint from initial product concept through life cycle management including potential pharma/combination products.

• Supports regulatory submissions, regulatory operations, change control, lifecycle management, interactions with regulatory agencies. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues.

• Provides regulatory policy, intelligence interpretation and strategy for pharma products to support global regulatory plans, due diligence, integrations and divestitures.

• Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues.

• Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability.

• Supports and develops global regulatory teams to meet company objectives.

• Minimum Bachelor’s Degree (pharmacy, biology, pharmacology) or related life sciences with 8 years of regulatory experience in the pharma industry. Relevant advanced degree in a scientific discipline is highly desirable.

• Experience in global regulatory strategy, and regulatory submission process.

• Proven experience in and ability to manage relationships and conduct meetings with regulatory agency personnel as well as support high visibility projects.

• Ability to present and make recommendations to senior management to drive proactive initiatives.

• Strong knowledge of pharma regulations

• Ability to travel up to 10 % of time, potentially internationally.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off. (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees

• This job is eligible to participate in our short-term incentive programs.

• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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.