AbbVie

US and Canada Area Lead, Global Regulatory Strategy, Immunology

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Jan 07, 2021
Ref
2100011
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.
  • This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director), in the development & execution of the regulatory strategy.Area of responsibility has significant regulatory impact and possibly significant impact to ABBV overall.
  • Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.May also serves as primary liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation 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.Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
  • Operates independently, with recognition of when to consult management.Makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction).Assists in the development, training, and mentoring of staff members.
  • Coordinates, prepares and/or supervises 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.Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
  • Demonstrates solid understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource & leads the department as a subject matter expert (SME) for Regulatory.
  • 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
  • Required Education: Bachelor's Degree (pharmacy, biology, pharmacology) or related life sciences.
  • Preferred Education: Relevant advanced degree is preferredCertification a plus
  • Required Experience: 8 years Regulatory, R&D or Industry-related experience
  • Preferred Experience: 5 years in pharmaceutical regulatory affairs.
  • Skill Set: Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization. Extensive experience interfacing with government Agencies and Health Authority personnel. Able to deliver challenging messages effectively without compromising important business relationships.
  • Skill Set cont'd: Experience working in a complex and matrix environment. Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization.Strong communication skills, both oral and written.
  • Skill Set cont'd: Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus.


*Position is flexible based on experience

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.