Senior Manager RA, Global Regulatory Strategy US at AbbVie

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn.

Purpose:

Responsible for the development and implementation of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. Assures that regulatory strategies are defined within the GRPT, are effectively implemented, and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant global regulatory requirements.

Responsibilities:

Responsible for a product or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, Director, or Senior Director), in the development and execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.

Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses. Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.

Functions independently in negotiation and decision-making for project related issues that have cross- functional impact. Assists in the development and training of staff members.

Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.

Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.

Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, as well as corporate policies and management-related considerations.

Presents pertinent regulatory information to appropriate cross-functional areas.

Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Qualifications:

Education equivalent to a PhD or MD degree or equivalent in a scientific field or experience in lieu of, plus at least 4 years experience in Regulatory Affairs; or

Education equivalent to a MS degree or equivalent in a scientific field or experience in lieu of, plus at least 6 years experience in Regulatory Affairs; or

Education equivalent to a BS degree or equivalent in a scientific field or experience in lieu of, plus at least 8 years experience in Regulatory Affairs

Demonstrates excellent negotiation skills, problem solving skills and builds consensus

Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization

Able to deliver challenging messages effectively without compromising important business relationships. Proven skill at implementing successful US and Canada regulatory strategies

Experience working in a complex and matrix environment. Global regulatory experience is a plus

Experience interfacing with government regulatory agencies

Computer literate with knowledge of EDMS systems for electronic storage and submission. Experience with Adobe Acrobat, MS Office, and ability to learn new computer programs

Additional Information

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 Companys sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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 protected veteran, or any other legally protected group status.