Regulatory Affairs Manager

Description

• Lead Allergan Aesthetic portfolio to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and to quality.
• Regulatory activities, including new product registrations, renewal registration, variations and maintenance of registered products, for Allergan Aesthetics with AbbVie’s policies compliance.
• Procedures are expected to meet statutory, quality and business requirements.
• Develop regulatory strategies and provide regulatory assessment for submission and approval plan.
• Responsible for review and approval of advertising/promotional material from regulatory perspective
• Support business and cross functional teams from regulatory perspective.
• Support maintenance of local SOPs and ensuring compliance with regulations.
• Monitor emerging trends regarding industry regulations.
• Other regulatory projects and tasks assigned by RA Head.

Qualifications

• University degree in Pharmacy or Pharmaceutical Science, or related disciplines.
• At least 7 years of regulatory experience in the pharmaceutical industry and/or medical device industry. Knowledge of Thailand regulations in medical device. Pharmaceutical knowledge would be an added advantage.
• Excellent analytical skills and ability to think strategically with local, regional, and global perspectives.
• High affinity in regulatory affairs intelligence with strong ability to provide sound advices and suggestions to the team.
• Ability to manage cross-functional team to achieve the goals and objectives with excellence of interpersonal skills, enthusiastic and a team player with positive attitude.
• Result oriented, agility and ability to work in a fast-paced environment
• Strong communication skills – both oral and written and proficiency in English and Thai to su the market requirements.