Job Description

PRIMARY FUNCTION/OBJECTIVE:
• Responsible for regulatory strategy, submissions and approvals for new product registrations, renewals, variations and maintenance of registered products. • Responsible for distributor management from regulatory perspective

• Keep updated of the current regulations related to therapeutic products and medical devices, seek clarification from the regulatory authority and industry, when necessary, assess regulatory and business impact, and provide regulatory strategies and updates to stakeholders

• Responsible to maintain local SOPs and ensure compliance with regulations are met • Represent Regulatory Affairs on Affiliate Management Team
• Responsible for providing input and approval on advertising/promotional materials for regulatory compliance. • Provide support to commercial team from regulatory perspective. CORE JOB RESPONSIBILITIES:

Regulatory Affairs:

• Primary contact with the regulatory authority in the country: To maintain and strengthen communication with the appropriate offices.
• Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
• Monitor, analyze and disseminate information on changes related to laws and regulations affecting registration, manufacture, distribution, and sale and marketing of AbbVie products
• Collaborate with local and area leadership and cross-functional teams and facilitate communication between Area Regulatory lead, and the local regulatory authority.

Product Registration and Maintenance:

• Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and long-range plan targets.
• Review, analyze and coordinate data for new product submissions, line and indication extensions, renewals, variations, and responses to regulatory authority questions, according to business priorities. Ensure that the content comply with government regulations prior to submission to regulatory authority.
• Maintain an awareness of country’s regulatory legislation and assesses its impact on AbbVie’s business.
• Monitor progress of marketing applications through the regulatory system.
• Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.

Adherence to regulatory business processes

• Maintain global and regional systems and databases to ensure that all relevant regulatory information is updated
• Ensure proper filing and maintenance of local documentation as per corporate procedures

Local SOPs and Policies Maintenance:

• Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with AbbVie global SOPs & policies and Regulatory Authority Department requirements.

Support to Sales and Marketing Activities:

• Monitor the progress of marketing applications and provide management with a monthly registration status in S&OP meeting and during brand team meetings as applicable.
• Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.
• Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.
• Support local business teams in tenders, hospital listings, and any other activities as required.

Medical, Pharmacovigilance (PV) and Quality Assurance Support:

• Guide and assist medical, PV or QA in regulatory requirements for respective countries.

Regulatory Intelligence:

• Keep abreast of changes in the regulatory environment in the country to ensure accuracy and effectiveness of regulatory submissions
• Develop regulatory intelligence network and maximize opportunities to expedite registration processes
• Conduct regulatory risk planning and mitigation procedures

• Bachelor’s Degree in Pharmacy or Industrial Pharmacy
• Registered and licensed Pharmacist with valid PRC ID License
• Minimum of 8 years experience in regulatory function dealing with pharmaceutical and/or medical device products
• Understands business needs and impact of regulatory issues
• Excellent analytical skills and ability to think strategically with local, area and global perspectives
• Strong interpersonal skills and negotiation skills
• Strong oral and written communication skills

Meticulous, organized, able to prioritize work, and a team player