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Labelling Specialist Regulatory Affairs At Abbot

 Labelling Specialist Regulatory Affairs At Abbot

Labelling Specialist Regulatory Affairs At Abbot



LOCATION EGYPT - CAIRO CATEGORY REGULATORY AFFAIRS

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, follow-up and implementation of new or modified labeling texts for METAP shared packs and country specific packs.
Liaison with internal departments and external partners to maintain labeling compliance on market.
Update current labels to comply with the latest approved labeling product information
Coordinate the creation or the update of local labeling
In charge of new product/packs artworks development
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
Execute artwork activities in relevant system including proofreading
Coordinate the review and approval from regulatory, medical and marketing as applicable
Manage and coordinate local language translations of PIL/labels
Responsible to perform assessment of the records in TrackWise system for the labeling updates and completion of implementation activities in accordance with HA, company requirements and timelines reporting in the change request action plan
Controls distribution of correct labels to packaging lines and implementation of correct material in the market
Track, follow-up and communicate implementation with support of SupplyChain and Quality
Manage, track and maintain approved labeling materials archives and database.
Ensuring tracking of regulatory activities in global regulatory tracking tools in accordance with related SOPs
Create and maintain local procedural 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
1.  PLANNING & COMPLIANCE TRACKING

Track
Identify, assess and report local regulatory requirements and seek approval from Global Labelling Committee when required
Maintain labelling history files and old versions of labels by retaining most current versions of Packaging/Prescribing Information Labels
Update regulatory information systems with submission status
2.  AFFILIATE COORDINATION

Maintain working relationships with defined countries and provides timely and high-quality support as per internal procedure
3.  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
Manage the preparation of registration packages and coordinate additional requests related to deficiency letters, safety-related inquiries and label deviations
Manage the preparation of the comparative table as needed
Prepare easy to read English text, coordinate translation and proof-reading for updated/translated labels
Follow-up on documentation availability, prepare cover letter, application forms and compiles submission dossier accordingly
Ensure internal approval for the complete submission dossier (Affiliates’ sign-off) prior to filing
Dispatch and archive submission dossiers
Coordinate labeling update submissions with regulatory experts and follow-up on approval.
4.   OPEN MOCKUP REQUEST FOR ARTWORKS DEVELOPMENT

Create Mockup Request in compliance with internal procedure
Provide necessary documentation and masters label
Ensure label meets local regulation
Coordinate proof reading and internal sign-off for updated artworks
5.  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
Implement process improvements
Regularly monitor, assess, interpret new local regulations and communicate impact accordingly
Maintain labelling procedures up-to-date
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
EDUCATION/QUALIFICATIONS/EXPERIENCE

EDUCATION:

Chemistry, Biochemistry, Pharmacy
Years of experience: 1-5 years (Regulatory, Labeling, Supply chain)
Minimum 3 years of relevant experience in Labelling
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 beyond Egypt is highly recommended.
Detailed oriented, communication, compliance and process Improvement skills.
Proficiency in English & Arabic languages; French is a highly recommended.
Computer Knowledge: Knowledge of Agile system & the Office package (Ms Word, Ms Excel, Ms Power Point)

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