AbbVie

Manager, Regulatory Affairs

Employer
AbbVie
Location
San Juan, PR, United States
Posted
Sep 18, 2020
Ref
2006650
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 .

The Manager, Regulatory Affairs, plans and executes Affiliate-level regulatory activities to drive compliance with local regulations and AbbVie policies and procedures. S/he is also responsible for managing all other local regulations impacting the distribution, marketing, and promotion of pharmaceutical products by the Affiliate. This role interfaces with Global, Area, and Affiliate-level partner functions (e.g. US Commercial, Quality Assurance, Supply Chain, Area Regulatory) to ensure Regulatory strategies are aligned with business objectives.

  • Effectively manages the submission of product registrations consistent within local requirements to drive complete, accurate, and timely information submission to local Health Authorities.
  • Collaborates cross-functionally to ensure Regulatory system records are kept up to date.
  • Interacts with stakeholders across functions to ensure that Regulatory activities support enterprise business objectives and strategies.
  • Supports the RA Director as needed to drive a culture of compliance and knowledge management across the affiliate.
  • Supports RA Director on audit readiness plans, hosting audits and inspections and working on required action plans and responses that drive resolution and guarantee continued compliant business operations.
  • Develops effective working relationships with local, US, and Area team members; prepares and delivers clear, relevant, and influential deliverables for a variety of audiences.
  • Effectively uses negotiation skills to resolve issues and drive completion of assigned tasks.
  • May represent Affiliate on cross-functional initiatives and externally, including local Health Authorities and Trade Associations.
  • May lead small team of 1-3 members and responsible to develop high performing talent, as applicable.

Qualifications

Required Education:

Bachelor's degree in Pharmacy or industry-related field

Preferred Education: Advanced degree(s) a plus (e.g., Pharm D, MBA)

Required Experience:
  • 8-10 years' related experience
  • Proven leadership skills and presence
  • Proven experience on regulations and standards impacting pharmaceutical products and medical devices registration, distribution, marketing, and promotion including experience interfacing with government and health authorities
  • Experience with Regulatory submissions in LATAM or US markets a plus
  • Strong strategic and critical thinking, attention to detail, and problem-solving skills
  • Superior project management skills and the ability to be multi-tasking while prioritizing effectively taking into consideration the organization's needs and risk management approach
  • Ability to be a self-starter and work independently
  • Excellent communication and active listening skills, with proven ability to successfully interact with different levels of stakeholders and work with cross-functional teams within the matrix organization
  • Demonstrated ability to lead, be influential, inspire others, persuasive and to present themselves appropriately through interpersonal relations/communications, even under considerable pressure to deliver results
  • Resilient and capable to change course of action as needed to ensure business continuity
  • Fluent English and Spanish, both verbal and written


Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.