Labeling Coordinator EMIRATI NATIONALS

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 Activities
• Assist 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.

Finance: Budget/ Headcount:

• Monthly expense report.

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 and

communicate 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 Marketing

o Product complaints and liabilities, where necessary

o Medical support and information (e.g. provide explanation on SmPC when needed) to sales force,

customers and end users.

People/Talent:

• Assist with training of AbbVie Middle East (Gulf/ Levant, Saudi Arabia & Egypt) affiliate staff on relevant Regulatory processes.

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

Desired Candidate Profile

• Creative self-starter capable of working autonomously, with an interest in developing this role and

continued 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.