# Officer, Regulatory affairs

- **Entreprise** : [IBN AL BAYTAR HIKMA](https://www.keejob.com/offres-emploi/entreprises/9622/ibn-al-baytar/)
- **Lieu** : Sidi Thabet, Ariana, Tunisie
- **Type de contrat** : CDI
- **Mode de travail** : Sur site
- **Niveau d'études** : Bac + 5
- **Expérience** : Entre 1 et 2 ans
- **Langues** : Français, Anglais, Allemand
- **Métiers** : Ingénieur / Industrie / Production, Pharmacien, Santé / Paramédical / Optique
- **Date de publication** : 2026-10-05
- **Date d'expiration** : 2026-11-04
- **Référence Keejob** : 248057
- **Statut** : Offre active

## Description

**Location:** Sidi Thabet

**Job Type:** CDI

**About Us**

For over 45 years, Hikma Pharmaceuticals has been putting better health within reach, every day, by creating high-quality medicines and making them accessible to those who need them. We are helping to shape a healthier world that enriches all our communities, and our global team of 9,500+ empowered employees are central to this mission.

As a trusted and reliable partner of over 800 high-quality generics, specialty and branded pharmaceutical products, we are driven to improve access to medicine. Through our 29 manufacturing plants, 9 R&D centers across the MENA, North America and Europe, our footprint allows us to play a critical role in serving patients. 

**Description:**

We are looking for a talented **Officer, Regulatory affairs  **to join us. At Hikma you’ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We’re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together.

If you want to be part of a team that cares about impact, this is the place for you.

### **Key Responsibilities**

  * Prepare, review, compile, and maintain **regulatory dossiers and supporting documentation** in line with applicable requirements.

  * Manage and follow up on regulatory activities related to **new product registrations, renewals, variations, and other post-approval activities**.

  * Support the preparation and submission of regulatory applications to the relevant **health authorities** and follow up on their progress.

  * Coordinate responses to questions, requests for additional information, and other communications received from regulatory authorities.

  * Ensure that product documentation and regulatory records remain **accurate, complete, compliant, and up to date**.

  * Contribute to regulatory assessments related to product changes and ensure appropriate regulatory actions are identified and followed.

  * Monitor changes and developments in the **regulatory environment** and support the evaluation of their potential impact on products and business activities.

  * Maintain effective communication and coordination with internal stakeholders, including **Quality, Medical, Supply Chain, Marketing, and other relevant functions**.

  * Support the preparation and maintenance of regulatory tracking tools, databases, and documentation.

  * Participate in cross-functional projects requiring Regulatory Affairs input and ensure regulatory considerations are adequately addressed.

  * Contribute to maintaining a strong culture of **quality, compliance, accuracy, and continuous improvement**.

### **Qualifications & Experience**

  * Degree in **Pharmacy, Engineering, Life Sciences, Pharmaceutical Sciences, or another relevant scientific discipline**.

  * Previous experience in **Regulatory Affairs within the pharmaceutical industry** would be highly valued.

  * Understanding of pharmaceutical product registration processes and regulatory documentation.

### **Key competencies**

  * Strong attention to detail and commitment to accuracy.

  * Excellent organizational, planning, and follow-up skills.

  * Ability to manage multiple priorities and work within defined timelines.

  * Strong analytical and problem-solving capabilities.

  * Good interpersonal and communication skills.

  * Ability to collaborate effectively in a **cross-functional environment**.

  * Proactive mindset with a strong sense of ownership and accountability.

  * Good command of **English and French** , both written and spoken.

  * Good proficiency in **Microsoft Office tools**.

## Postuler

Postulez directement sur Keejob : https://www.keejob.com/offres-emploi/248057/officer-regulatory-affairs/

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Source : Keejob.com, le site de l'emploi en Tunisie.