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.
• Primary contact with Regulatory Authority in Thailand for responsible products.
• Facilitate communication between Area Regulatory lead and the local regulatory authority.
• Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and targets.
• Ensure that the regulatory strategy is designed to deliver timely approval with desired labeling.
• Execute manage new product submissions, line extensions, variations, renewal registration according to priorities and responses to deficiency letters. Ensure that the content comply with government regulations prior to submission to Regulatory Authority.
• Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
• Monitor and disseminate information on changes related to the Regulatory Authority Department: law & regulations affecting registration, manufacture, distribution and sale & marketing of Allergan Aesthetic products.
• Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
• Provide regular registration status to RA Head.
• Communicate regulatory issues and evaluate the impact on the business to management, Business Unit, where applicable.
• Manage labelling changes, artwork development and artwork approval of packaging material components.
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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.