Regulatory Affairs Manager

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

•  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.

CORE JOB RESPONSIBILITIES

Product Registration and maintenance

• 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.

Business Support

• Work cross-functionally as required to meet business needs.
• Support local business teams in activities such as tenders, as required, from a regulatory perspective.
• Review and provide input and approval on promotional materials, from regulatory perspective.
• Provide regulatory input and support for marketing plans, product launches and other cross-functional activities.
• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Monitor the progress of marketing applications and provide management with a monthly registration status in (Sales & Operation Planning) S&OP meeting and during brand team meetings as applicable.
• Implement regulatory activities in support of lifecycle management in line with business needs.
• Collaborative with supply chain to ensure timely maintenance of product labels to ensure compliance to Abbvie requirements, and continuity in supply.

Processes

• Maintain global systems and databases to ensure that all relevant regulatory information is updated.
• Manage Allergan Aesthetic regulatory systems and SOPs to comply the corporate policy.
• Lead or participate in projects to streamline RA processes to increase productivity, where applicable.

Compliance

• Responsible for review and approval of advertising and promotional materials and campaign/events from regulatory perspective, collaborating with business partners.
• Maintain good knowledge of relevant regulatory corporate policies and ensure compliance.
• Update local SOPs and policies relevant to Regulatory Affairs to comply with AbbVie global SOPs & policies and Regulatory Authority requirements.
• Provide timely and accurate input to regulatory assessments of products where requested.
• Support sales and marketing colleagues by providing adequate and relevant regulatory information.
• Hold pharmacist licence for company, if required and where applicable.

Regulatory Intelligence

• Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
• Keep abreast of changes in the regulatory environment to assure accuracy and effectiveness in regulatory submissions.
• Monitor on changes related to the Regulatory Authority on law & regulations affecting registration, manufacture, distribution, and sale & marketing of AbbVie products.
• Maintain an awareness of country’s regulatory legislation and assess its impact on AbbVie’s business

People/Contractor Management (where applicable)

• Lead and provide guidance to team member/contractor to prioritize and meet target goals and objectives in a timely manner

• 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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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