Regulatory Affairs Specialist - Egypt and Levant

Position Summary

Accountable for the achievement of the local affiliate, Cluster and Corporate objectives, in collaboration with the affiliate RA Manager to support in RA Egypt affiliate and Levant region, and provide Regulatory Affairs support to the local affiliate to help the market(s) achieve their revenue and growth targets:

• Obtain new product registrations and special import permits in line with local and regional strategies and renew or extend them as necessary.
• Maintain product registration files, including submission of variation applications as necessary, with respect to changes in manufacturing, product testing and specifications, safety and efficacy information, and/or changes in local regulations.
• Represent Zoetis to the Competent Authorities for all product registration activities.

Roles and Responsibilities

• Submission of new product registrations in line with the market objectives.
  • Submit and implement a plan for obtaining the agreed new product registrations.
  • Ensure that the plan is fully aligned and integrated with any regional or cluster regulatory plans and report status, metrics and key performance indicators.
• Facilitate registration of new products and maintenance of existing product registrations.
  • Submission and follow-up of requests for registration dossiers, certificates and product samples.
  • Review of variation dossiers and determination of regulatory strategy for each proposed change in manufacturing, specification, safety or efficacy to ensure regulatory compliance at all times.
  • Compilation, translation and submission of registration dossiers, including payment of fees.
  • Submission and follow-up of requests for responses to questions and additional information to Competent Authority (EDA, NODCAR, GOVS; CLEVB & etc).
  • Preparation and/or approval of product labels and package inserts in accordance with the registration file & market requirements.
  • Archiving of regulatory documents, submissions, queries, approvals and correspondence, in accordance with market SOP & VMRD requirements.
  • Discussion with Regulatory Authorities (EDA, NODCAR, GOVS, CLEVB & etc) to facilitate product registration and maintenance.
• Support marketed products.
  • Ensure CPP’s (Certificates of Pharmaceutical Product) & manufacturing site GMP status meets the requirements of each market.
  • Obtain and upload Special Import Permits into GTS and assist ZOM Regulatory Affairs and GTS team in the resolution of GTS blocks.
• Develop and maintain knowledge of regulatory requirements at National and Regional level.
  • Participate in regulatory affairs activities within the National Animal Health Industry Federation.