Skip to main content

Search jobs

Search jobs

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.

Regulatory Affairs Director

Taipei, Taiwan, Taiwan Req ID 2207112 Category Regulatory Affairs Division AbbVie
  • Represents department and participates in meetings with US Commercial. Represents Regulatory on Global Regulatory Product Team (GPRT) and ADTs as appropriate. Advises on region specific requirements and provides strategic input.
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Ensures departmental training and compliance with established regulations, guidance’s and SOPs related to regulations for self and direct reports. Manages direct reports and assist in the development, training and mentoring of staff members
  • Effectively presents pertinent information to appropriate cross-functional groups. Effectively delivers difficult messages to commercial organization without damage to relationships
  • Establishes solid relationships with management and key stakeholders fostering mutually beneficial interactions and exchange.
  • Assesses R&D programs against region 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
  • Supervises the preparation and review of regulatory submissions consistent within a geographic region, Regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review
  • Serves as Health Authority liaison and interfaces with Health Authorities for meetings, teleconference, etc. Coordinates preparation of Health Authority meeting briefing packages
  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus. Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.

  • Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related
  • Preferred Education: Advanced Degree a plus. Certifications a plus
  • Required Experience: 7 years Regulatory, R&D or industry related experience
  • Proven skill at implementing successful global regulatory strategies
  • Experience working in a complex and matrix environment
  • Preferred Experience: 2-3 years’ experience in pharmaceutical regulatory activities
  • Experience interfacing with government regulatory agencies
Travel: Yes, 20 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation