Browse Jobs
For Employers
Post JobLog inGet Started

Regulatory Affairs Associate

GSK
Cairo, Egypt
Posted 4 years ago
210People have clicked1 open position
Search other opportunities

Job Details

Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:

Skills And Tools:

Job Description

job Purpose:

Evaluation, preparation, coordination &submission of regulatory documents in compliance with local regulations

  • Ensure regulatory compliance, timely submissions & secure regulatory approval in GNE markets.
  • Managing all the internal processes between GNE-RA and the central team.
  • Enable the company to achieve its objectives by obtaining marketing authorization approvals/ license maintenance on time.
  • Strategic planning for life cycle maintenance.
  • Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment.
  • Communication and maintenance of product registration to ensure alignment with all stakeholders.

Core Responsibilities:

  • Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment.
  • Ensuring proper communication of all WIP by updating eForms.
  • Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements.
  • Manufacturing site registration and license maintenance.
  • Responsible for coordinating the MSRs to ensure right first time dossiers are provided.
  • Coordinate and respond o the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals.
  • Establish effective communication and continuous follow-up with the external agencies & distributors to ensure timely submissions and approvals of all company’s applications.
  • Continuous monitoring of any changes on the existing rules or any new regulations.
  • Providing artwork creation support to all GNE Markets, through using the supportive documents & complying with the company SOPs & local guidelines in a timely manner.
  • Follow up to ensure that the locally manufactured/packaged artwork (if applicable) is compliant with the latest label updates.
  • Authorize approval of technical changes in artwork/ GEXP updates.
  • Responsible for follow up with translation providers for timely provision of Arabic text to be incorporated to Local leaflets.
  • Announcement of regulatory approvals to all concerned stakeholders.
  • Maintenance of all lifecycle activities/ Product Detail Set in OPAL by accurately updating all submissions and approval within the preset global timelines.
  • Renewal event creation for active licenses for the respective GNE Markets
  • Review of regulatory information enclosed in technical terms of supply prepared by QA.
  • Ensure alignment of regulatory objectives with GNE strategies, regional / global regulatory objectives and commercial plans.

Scope:

Market authorisation approvals and lifecycle maintenance activities in Gulf and Near East Markets (UAE, Kuwait, Qatar, Bahrain, Oman, Jordan, Lebanon, Syria & Iraq)

Accountability:

  • Timely submissions and approvals of all regulatory dossiers, to ensure supply compliance with the registration details.
  • Building professional relationships with all stakeholders internally and externally
  • Accountable for ensuring implementation of in scope GSK Global and Local SOPs, policies and procedures in all activities and tasks.
  • Accountable for maintenance of all lifecycle activities in the regulatory eForms database and OPAL.
  • Identifying all potential risks and update to all relevant stakeholders.
  • Complying to local authority guidelines
  • Accountable for ensuring labeling compliance to the latest labeling information.

Job Requirements

Qualifications:

  • Bachelors of pharmacy.
  • Awareness of Regulatory systems such as OPAL , IMMS , CMAC ,Vault or equivalence
  • Fluent spoken English
  • Awareness of preparation for ctd and rebaseline files
  • Awareness of EU registration guidelines

Experience:

  • Minimum 1- 2 year experience in regulatory affairs.

High Performance Behaviours:

  • Highly enthusiastic, self motivated, committed and dedicated personality. o Positive attitude towards creating business solutions. o Good communication skills (both verbal and in writing). o Ability to work independently as well as in teamwork. o Capacity to establish positive interpersonal relations and interact effectively with cross functional teams
  • Capacity to work accurately under pressure to meet project timelines.
  • High attention to details.
  • Ability to work in a fast- paced, technically skilled, team setting.

Featured Jobs

  • MLRO/AML Compliance OfficerConfidential Company - Cairo, Egypt12 days ago
  • Export Regulatory Affairs Phar... - Obour City, Cairo2 months ago
    Logo

Similar Jobs

Search other opportunities
JobsLegalRegulatory Affairs Associate