Regulatory Affairs Specialist

Company: Pharma Advisor

Location: Manial, Cairo

Department: Regulatory Affairs

Employment Type: Full-Time

Job Description

Pharma Advisor is looking for a motivated and detail-oriented Fresh Graduate to join our Regulatory Affairs team as a Regulatory Affairs Specialist.

The role will provide hands-on exposure to pharmaceutical regulatory activities, including product registration and regulatory submissions across Egypt and GCC markets, as well as supporting import and export regulatory activities.

Key Responsibilities

* Assist in the preparation and submission of regulatory dossiers for pharmaceutical products.

* Support product registration activities with the Egyptian Drug Authority (EDA) and National Food Safety Authority (NFSA).

* Assist with regulatory registration and compliance activities across GCC countries.

* Support regulatory activities related to pharmaceutical imports and exports.

* Prepare and maintain regulatory documentation and product files.

* Assist in responding to regulatory authority queries and comments.

* Monitor regulatory guidelines and requirements relevant to assigned markets.

* Coordinate with internal teams and clients to ensure regulatory requirements and submission timelines are met.

* Support ongoing regulatory activities throughout the product lifecycle.

Requirements

Education:

* Bachelor's degree in Pharmacy.

Experience:

* Fresh graduates are encouraged to apply.

* Previous internships, training, or academic projects related to Regulatory Affairs, pharmaceutical registration, or the pharmaceutical industry are a plus.

Skills:

* Good understanding of pharmaceutical regulatory principles is preferred.

* Strong attention to detail and organizational skills.

* Good written and verbal communication skills in English.

* Ability to work effectively within a team.

* Good knowledge of Microsoft Office (Word, Excel, PowerPoint).

* Strong analytical and problem-solving skills.

Personal Attributes

* Proactive and eager to learn.

* Detail-oriented and organized.

* Able to work under pressure and meet deadlines.

* Strong willingness to develop a career in Regulatory Affairs.

* Good communication and teamwork skills.

What We Offer

* Hands-on exposure to pharmaceutical Regulatory Affairs.

* Training and mentorship in regulatory submissions and registration.

* Exposure to EDA, NFSA, and GCC regulatory requirements.

* Opportunities for professional development and career growth.

* Collaborative and dynamic work environment.

How to Apply

Interested candidates can apply through LinkedIn Easy Apply.

Alternatively, you can send your CV to:

[Confidential Information]