AbbVie

Associate Analyst, Regulatory Affairs

Employer
AbbVie
Location
PR, United States
Posted
Oct 08, 2020
Ref
203759
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 .

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

The Regulatory Affairs Associate Analyst is responsible for product registration activities from planning through submission and approval stage, ensuring accurate and timely submissions with local Health Authorities and internal systems. The role will interact and collaborate with Area and Affiliate-level teams as required and will work with different systems and platforms to collect and validate accuracy of working source data. Responsible for supporting processes to enable Commercial launch and product marketing activities are supported on a timely and compliant manner.

YOU ARE more than just a title, YOU ARE...
  • First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will
  • Perform Regulatory submission activities in compliance with local regulations and AbbVie procedures.
  • Have a deep understanding of systems (internal and external) to manage product registrations in a timely manner. Activities include but not limited to:
    • Request and/or source applicable documents from Global/Area or established sources (internal or external)
    • Review and evaluate documentation sourced
    • Adapt documentation to meet systems' requirements (e.g., create PDFs, zip files)
    • Drive accurate product registrations ensuring first time quality
    • Track and archive agency approvals responses
    • Drive accurate registration submissions and approvals documentation uploading into company systems ensuring first time quality
  • Create and maintain required working tools to track and plan for regulatory registration and maintenance activities.
  • Propose solutions and strategies to accomplish registration activities in times of systems failures or local agency rule changes.
  • Monitor and inform RA Management of regulatory policy changes impacting local business process and requirements
  • Support RA Management on RA internal/external audits readiness, inspections, and action plans
  • Incorporate diverse, cross-functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.

#LI-PD1

Qualifications

You Bring
  • Bachelor's degree in industry-related field
  • Degree in Pharmacy a plus
  • 1-3 years' experience working on Product Registration in Puerto Rico and related industry activities
  • Knowledge on regulations and standards impacting pharmaceutical products and medical devices distribution, marketing, and promotion
  • Leadership skills and presence
  • Excellent verbal and written communication skills
  • Good critical thinking, attention to detail, and problem-solving skills
  • Effective use of negotiation skills to resolve issues to ensure completion of assigned tasks
  • Resiliency and ability to change course of action as needed to ensure business continuity
  • Proficiency in English and Spanish, both verbal and written

In this role, we're looking for a leader who will :
  • Act as an Owner
  • Be Excellence Focused
  • Act as an Influencer


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.