Labeling Coordinator EMIRATI NATIONALS

Abbvie Biopharmaceuticals GMBH - REP.OFFICE; Dubai, Al Ain; On-site; AED 120,000 - 240,000; Full time

Job summary

AbbVie Middle East affiliate in Dubai is seeking a Regulatory Labeling Specialist to coordinate labeling activities for the Middle East Gulf Levant region. You will lead preparations of SmPCs, PILs, and labeling for regulatory submissions, ensure GLS uploads, and maintain labeling documents in line with local laws.

You will collaborate with Regulatory Affairs, Marketing, and Manufacturing to implement labeling changes on time.

Qualifications

• Bachelor degree.
• Proficiency in written and spoken English.
• IT literate and able to use labeling systems.

Responsibilities

• Coordinate labeling activities for the Middle East Gulf Levant region.
• Prepare SmPCs, PILs and labeling for regulatory submissions.
• Upload to GLS and manage local product information documents.
• Communicate labeling changes to local Marketing, Sales and Medical teams.
• Ensure compliance with local regulatory requirements and timelines.
• Support cross-functional teams (Marketing, Sales, Medical) on labeling changes.

Skills

Administrative skills

Project management

Communication skills

Problem solving

Attention to detail

Education

Bachelor degree

Tools

GLS (Global labeling system)

Job description

Position Title Regulatory Labeling Specialist

Regulatory Affairs

Main purpose

Act as a coordinator for the labeling procedure in Middle East Gulf Levant Saudi Arabia Egypt Support Regulatory Affairs for AbbVie Middle East affiliate Affiliate for all AbbVie Pharmaceutical products

Main Responsibilities

Advance Pipeline Marketed Product Support Submissions Renewals Approvals Monitoring of local regulatory requirements and their communication within AbbVie Keep abreast of emerging legislation and highlight the potential impact on the business Preparation of SmPC s PIL s and labeling in accordance with legal and regulatory requirements Uploading to Global labeling System GLS of all submitted to local product information PI and related documents through National Labeling Update NLU Creation proofreading and approval of Polish labeling text mock-ups artworks and PILs Support communications to local Marketing Sales and Medical personnel relating to SmPC PIL changes prior to their implementation Packaging projects and implementation control coordination of labeling activities for Middle East- artwork development liaison with labeling centers database management Collaborate with Demand Manager in order to implement the updated artwork in a timely manner Preparation and filing of regulatory submissions in a timely manner Maintenance of existing pharmaceutical product marketing authorizations and monitor regulatory authority approval for the variations of these authorizations Monthly reporting Summary of all Labeling ActivitiesAssist with immediate notification of any regulatory requests including safety labeling changes urgent safety restriction requests as well as external inspections Assist in special projects

Compliance Training

Keep the assigned Regulatory Labeling databases on the server up to date Ensure compliance with statutory local regional EU and AbbVie corporate regulations Responsible for execution of the training and education Take ownership for management of the Rewards and Recognition process when appropriate

Regulatory Excellence

Cooperate and liaise with manufacturing sites corporate head-office and other AbbVie Middle East affiliate departments Establish and maintain good relationship with all involved regulatory institutions in Middle East Gulf Levant Saudi Arabia Egypt Identify and track changes trends in the authorization practice and attitudes in Middle East andcommunicate them within AbbVie Coordinate and ensure effectiveness of Regulatory Affairs function Support Launch Excellence process within the AbbVie Middle East affiliate

Transforming the Organization

Participate in local brand teams to assist with product development and project planning to ensure that the proposed development plans account for regulatory requirements throughout the process Support business development in the market Coordinate activities that assist product areas by providing support for o Sales and Marketingo Product complaints and liabilities where necessaryo Medical support and information e g provide explanation on SmPC when needed to sales force customers and end users

General Responsibility

To comply with the company s policies and procedures to meet statutory quality and business requirements within the overall strategy and objectives of AbbVie

Accountability

Responsible for presentation and accuracy of documentation submitted to regulatory authorities This is a position in which with appropriate supervision a significant level of autonomy is anticipated along with project responsibility Accountable to Regulatory Affairs Head Gulf Region Creative self-starter capable of working autonomously, with an interest in developing this role andcontinued training.Good problem solving skills and the ability to work to tight deadlines.Effective project management and communications skills.Team player with the ability to work cross functionally.Thorough attention to detail and high standards of accuracy.Strong administrative skills.Good knowledge of local registration requirements.Previous experience of working in a similar position in a multi-national pharmaceutical company preferred.

Education:Bachelor degree.

Proficiency in written/ verbal English language.

IT conversant.