AbbVie

Manager, Regulatory Affairs Area & Affiliate - Latin America (Oncology)

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Jan 08, 2021
Ref
2009281
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 .

**LOCATION: Lake County, IL OR Remote**

The Manager Regulatory Affairs Area & Affiliates implements regulatory strategies and priorities in conjunction with Global Regulatory Lead (GRL) and Global Regulatory Product Team (GRPT) colleagues, as appropriate. Identifies and obtains data needed and ensures all is effectively presented for submissions to Health Authorities. Manages the regulatory submission and approval process and serves as liaison with Health Authority for routine communications in support of filings. Ensures within its region the application of established policies and best practice regulatory standards for all filings, maintenance of existing product registrations and agency interactions. Assists Regulatory Staff by identifying and providing data needed to support filings, responses to HA inquiries and registration maintenance. This position may develop and supervise others.

Responsibilites:
  • Assesses R&D programs against regional specific regulatory requirements
  • Influences internal customers on Regulatory Health Authority issues including commercial, public affairs, clinical development, legal, and others who contribute to regulated communication
  • Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines and assures complete and timely response to Health Authority during application review
  • Represents A&A on Global Regulatory Product Team (GPRT) and ADTs as appropriate. Advises on regional specific requirements and provides strategic input.
  • Serves as Health Authority liaison and interfaces with Health Authority for meetings, teleconference, etc. Coordinates preparation of Health Authority meeting briefing packages
  • Demonstrates good negotiation skills and builds consensus. Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
  • Recommends and implements changes to complex projects based on knowledge and expertise, accurate interpretation of government regulations, guidances, corporate policies and management related considerations.
  • Disseminates/presents pertinent information to appropriate cross-functional areas.
  • Employs logic and methods to independently and effectively/creatively solve difficult problems. Uses problem solving skills to separate and combine tasks into efficient workflow.
  • Assures that established policies and standard interpretation of regulations are communicated and followed for assigned projects. Provides regulatory direction regarding marketed products and products in development to support the development of compliant and competitive programs.

Qualifications

Qualifications:
  • Required Education: Bachelor's degree (pharmacy, biology, chemistry, pharmacology) or industry related
  • Preferred Education: Advanced Degree a plus. Certifications a plus
  • Required Experience: 6 years industry related, Regulatory or R&D experience
  • Proven skill at implementing successful global regulatory strategies
  • Experience working in a complex and matrix environment. Good communication, both oral and written
  • Preferred Experience: 2-3 years' experience in pharmaceutical regulatory activities
  • Experience interfacing with government regulatory agencies
  • Preferred: fluent in Spanish

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, 15 % 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.