METAP labelling Team Leader

JOB DESCRIPTION:

About Abbott:

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people.

Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.

JOB PURPOSE AND SCOPE

Support managing labelling activities within the METAP coverage areas to ensure activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements. Overall scope consists of providing support to Regulatory Affiliate in oversight of all related labelling activities, primarily in:

• Coordination of submission planning, preparation, review of new or modified labelling texts for METAP shared packs and country specific packs in collaboration with affiliates.
• Liaison with internal departments and external partners (Third Party Manufacturers) to collect needed information enabling labelling preparation & maintenance in compliance with local market requirements.
• Create & share Updated labels ready for submission package with local affiliate to comply with the latest approved labeling product information.
• Manage and coordinate local language translations of PIL/labels as applicable.
• Coordinate the workflow of the label change for local & regional labeling using validated tools & systems including proofreading.
• Coordinate in collaboration with local affiliates the review and approval from regulatory, Medical and marketing as applicable.
• Track, follow-up and communicate implementation with support of Supply Chain and Quality
• Manage, track and maintain approved labeling materials archives and database.
• Ensure that changes/new creations are approved and implemented on time to meet HA commitments and internal compliance guidelines while maintaining uninterrupted and optimized supply for operations.
•  Create and maintain local procedures & documents as needed.
• Act as subject matter expert for labeling related activities and procedures and perform regular training as needed.
• Identify labeling issues (as errors, inconsistencies and conflicts) between package leaflet and SmPC and take the lead to solve such issues.
• Perform any other duties as requested by the management.
• Optimize the use of the company resources while fulfilling the above activities.
• Support in Pharmacovigilance Local & Regional Audits preparation & execution as applicable
• Ensure record retention (archiving)

Submission Execution and Compilation

• Advise Business Partners (Portfolio Expansion Lead, Global Labelling Group) on MEAP local regulatory requirements.
• Identify/obtain required documentation and ensure content meets requirements for the registration of labelling changes.
• Prepare and coordinate registration packages, including responses to deficiency letters, safety inquiries, and label deviations.
• Develop comparative tables and English text; coordinate translations and proofreading.
• Follow-up on documentation availability (CPP, Ref. country approval letter…etc)
• Secure internal approvals before submission, dispatch dossiers, archive files, and track approvals with affiliates.

Regulatory Intelligence & Process Improvement

• Identify and recommend opportunities for improvement to the labelling processes, quality, systems, tools and policies. Benchmark existing processes against external processes.
• Maintain regional labelling procedures up-to-date.
• Identify, recommend, and implement process and quality improvements.

Talent development:

• Retains talents, ensure development and diversity while facing increasing demands, and while maintaining efficiencies and effectiveness
• Encourages a growth mindset for a skilled and valuable task force
• Works on career plans aligned with the individuals career goals and company needs

Technical/Functional Skills Required

• Precision and accuracy in task execution
• Flexibility
• Assiduity and hard working
• Ability to manage multiple projects at the same time and deliver results within deadlines
• Ability to work under pressures and deadlines
• Critical thinking and ability to challenge the status quo
• Strong communication skills
• Detail-oriented

Education/Qualifications/Experience

Education:

• Chemistry, Biochemistry, Pharmacy
• Years of experience: 3-5 years (Regulatory, Labelling, Supply chain)

• Knowledge of labelling requirements procedures, policies and standards
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
• Regional experience is highly recommended.
• Detail-oriented, communication, compliance and process Improvement skills.
• Proficiency in English & Arabic language
• Computer Knowledge: Knowledge of Agile system & the Office package (Ms Word, Ms Excel, Ms Power Point)

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma

LOCATION:

Egypt > Cairo : KTC Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable