Senior Regulatory Affairs

Job Summary

The Senior Regulatory Affairs is responsible for overseeing and executing all regulatory processes required to register the companys products and services with relevant government bodies including but not limited to Ministries of Health Industry Agriculture Food and Drug Authorities Customs Authorities and Standards Agencies in Egypt KSA UAE and other operating markets. This includes ensuring full compliance with applicable laws regulations and standards for product approvals labeling and trade licenses.

Key Responsibilities:

1. Product & Service Registration:

• Lead and manage product registration processes for all categories (food beverages non-food supplies medical and cosmetics) across relevant regulatory authorities.
• Submit and track dossiers and documentation to MOH Ministry of Industry SFDA GSO and any applicable national bodies.
• Ensure timely renewal of existing registrations and licenses.

2. Regulatory Compliance:

• Stay updated with all regulatory changes and ensure company compliance with local and international requirements (Codex ISO GSO EU standards if exporting/importing).
• Ensure product labels ingredients claims packaging and shelf-life comply with local and importing country laws.
• Coordinate with internal departments (Procurement QA/QC Supply Chain Sales) to ensure regulatory requirements are met before commercial activity.

3. Documentation & Filing:

• Develop and maintain a centralized regulatory archive of product dossiers technical sheets lab test results health certificates and approvals.
• Review and verify accuracy of all required documents including product specs MSDS Halal certificates and declarations of conformity.

4. Coordination with Principals & Partners:

• Work directly with global suppliers and brand owners to obtain required documentation and ensure their product specifications comply with local standards.
• Coordinate with legal consultants and certification bodies for third-party audits or accreditations.

5. Regulatory Intelligence & Advisory:

• Advise management and relevant teams on any risks or delays related to product registration or compliance.
• Provide guidance for new product launches from a regulatory standpoint (e.g. import feasibility claims allowed required approvals).
• Assist in establishing internal SOPs to streamline regulatory processes across markets.

6. Audits & Inspections:

• Prepare and lead regulatory audits or inspections by authorities or certification bodies.
• Ensure all corrective actions are implemented when required by regulatory agencies.

Job Requirements

Qualifications:

• Education: Bachelors degree in Pharmacy Food Science Biotechnology Veterinary Medicine or a related scientific field.
• Experience: 46 years of experience in regulatory affairs within the FMCG foodservice pharmaceutical or healthcare sector.
• Knowledge: Strong familiarity with SFDA (KSA) MOH (Egypt UAE) Codex Alimentarius GSO and other regional regulatory frameworks.
• Languages: Fluent in Arabic and English (written and spoken).
• Tech Skills: Proficiency in MS Office Suite documentation systems and regulatory portals for online submissions.

Key Competencies:

• Strong attention to detail and accuracy
• Excellent organizational and documentation skills
• High level of integrity and confidentiality
• Ability to manage multiple projects and deadlines
• Strong communication and cross-functional collaboration skills
• Proactive problem solver and results-oriented mindset

is responsible for overseeing and executing all regulatory processes required to register the companys products and services with relevant government bodies including but not limited to Ministries of Health Industry Agriculture Food and Drug Authorities Customs Authorities and Standards Agencies in Egypt KSA UAE and other operating markets. This includes ensuring full compliance with applicable laws regulations and standards for product approvals labeling and trade licenses.

Key Responsibilities:

1. Product & Service Registration:

• Lead and manage product registration processes for all categories (food beverages non-food supplies medical and cosmetics) across relevant regulatory authorities.
• Submit and track dossiers and documentation to MOH Ministry of Industry SFDA GSO and any applicable national bodies.
• Ensure timely renewal of existing registrations and licenses.

2. Regulatory Compliance:

• Stay updated with all regulatory changes and ensure company compliance with local and international requirements (Codex ISO GSO EU standards if exporting/importing).
• Ensure product labels ingredients claims packaging and shelf-life comply with local and importing country laws.
• Coordinate with internal departments (Procurement QA/QC Supply Chain Sales) to ensure regulatory requirements are met before commercial activity.

3. Documentation & Filing:

• Develop and maintain a centralized regulatory archive of product dossiers technical sheets lab test results health certificates and approvals.
• Review and verify accuracy of all required documents including product specs MSDS Halal certificates and declarations of conformity.

4. Coordination with Principals & Partners:

• Work directly with global suppliers and brand owners to obtain required documentation and ensure their product specifications comply with local standards.
• Coordinate with legal consultants and certification bodies for third-party audits or accreditations.

5. Regulatory Intelligence & Advisory:

• Advise management and relevant teams on any risks or delays related to product registration or compliance.
• Provide guidance for new product launches from a regulatory standpoint (e.g. import feasibility claims allowed required approvals).
• Assist in establishing internal SOPs to streamline regulatory processes across markets.

6. Audits & Inspections:

• Prepare and lead regulatory audits or inspections by authorities or certification bodies.
• Ensure all corrective actions are implemented when required by regulatory agencies.

Job Requirements

Qualifications:

• Education: Bachelors degree in Pharmacy Food Science Biotechnology Veterinary Medicine or a related scientific field.
• Experience: 46 years of experience in regulatory affairs within the FMCG foodservice pharmaceutical or healthcare sector.
• Knowledge: Strong familiarity with SFDA (KSA) MOH (Egypt UAE) Codex Alimentarius GSO and other regional regulatory frameworks.
• Languages: Fluent in Arabic and English (written and spoken).
• Tech Skills: Proficiency in MS Office Suite documentation systems and regulatory portals for online submissions.

Key Competencies:

• Strong attention to detail and accuracy
• Excellent organizational and documentation skills
• High level of integrity and confidentiality
• Ability to manage multiple projects and deadlines
• Strong communication and cross-functional collaboration skills
• Proactive problem solver and results-oriented mindset

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