Officer, Regulatory affairs

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.