Sr. Associate, Labelling

 JOB PURPOSE:

The main purpose of this role is to implement the following business processes:

• Product Labelling text creation

• Packaging materials review

• Labelling project management

 

Supporting activities concerned with Regulatory Affairs:

• Provision of prepared labelling documents to be submitted in the RA submission files.

• Supporting in MOH/authorities queries in terms of Product labelling.

 

Supporting activities concerned with marketing and Operations:

• Providing labelling materials that serve the marketing strategies in new product introduction

• Product labelling management related to product re-registration & Rx to OTC Switch

• CHC product labelling creation

 

The job holders are responsible for product labelling creation and review. The job holder is in more interaction with internal and external parties to follow up on new activities. Additionally, the job holder is responsible for reviewing, analyzing and approving Labelling documents with auditing associate work to maintain high quality. They follow-up with regulatory department associate/seniors to ensure meeting the submission (approval deadlines).

 

The job holder is expected to manage all packaging text creation processes, including approval tracking and documentation; and to effectively contribute to the achievement of the Product Labelling plans.

 

 

4. KEY ACCOUNTABILITIES:

Description

Performance Indicators

Policies & Procedures

• Implements approved departmental policies and procedures and ensures adherence with the processes implemented so that work is carried out in a controlled manner.
• Follow and implement Labelling SOPs and Guidelines to ensure all relevant procedures and requirements are fulfilled on all assigned projects.

 

• Adherence to procedures.
• Adherence to SOPs

 

Day to day operations

• Implements the day-to-day operations assigned for the function to ensure compliance with the established standards and procedures.
• Follows up regularly with internal departments on related requests to ensure meeting deadlines (through TCs and meetings).
• Updates and maintains the archive.
• Collects and evaluates data for the aim of preparing more complex reports.
• Identifying labelling information from various source documents and collecting needed data from Hikma different teams and sources, and data related to reference product information.
• Authoring of labelling documents; including SPCs, package insert, PILs; etc. through Veeva- and/or Microsoft Office-based cycles.
• Proposing of labelling texts for Hikma packaging materials (i.e. outer packs, inner labels, blisters; etc.) through RIMS- and/or Microsoft Office-based cycles.
• Reviewing of Hikma packaging materials (i.e. outer packs, inner labels, blisters; etc.).
• Following product labelling requests plans in order to ensure on-time delivery. 
• Trains and coaches associate to develop their work skills and motivate them to work to their best potential and reviewing of labelling deliverables to ensure compliance with applied procedures and regulations, as prepared by newly hired staff and as seen needed.
• Manages projects in terms of resources, plans, under supervision of higher-level jobs.
• Ensuring on-time completion of deliverables, and communicating product labelling projects status, challenges, and successes to their direct manager.
•  

• Smooth flow of day-to-day operations.
• Delivery vs. deadlines
• Internal customer satisfaction
• Alignment with PL and submission plans
• Self and associate report achievements versus plan

 

Job related – Special Accountabilities

• Working with the different Hikma teams for collecting and assessing product labelling requirements.
• Communicating with Hikma affiliates to ensure implementation of applicable procedures in order to ensure consistent product labelling across MENA; where applicable.
• Handling the communications with the licensors and Hikma affiliates (manufacturing sites) to ensure on time submissions and approvals.
• Handling other product labelling projects assigned by the supervisor.

• Managing the projects assigned

6. QUALIFICATIONS, EXPERIENCE, & SKILLS 

QUALIFICATIONS

•  BSc. in Pharmacy, Doctor of pharmacy or Chemical pharmaceutical engineering, or equivalent lifeschiences.

EXPERIENCE

• 5+ years of related experience Regulatory Afffairs or Labeling 

SKILLS

• Time management
• Communication
• Microsoft office skills