Title:  Associate, Regulatory Affairs

Location: Casablanca, Morocco

Job Type: Full-time

Hashtag: #LI-MM1

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, Regulatory Affairs Associates 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:

• Review and ensure the compliance of regulatory dossiers before submission.
• Prepare, compile, and manage regulatory dossiers for Marketing Authorization Applications (MAAs), renewals, and variations.
• Follow up on submitted dossiers throughout the evaluation process until approval is obtained.
• Work closely with R&D, Marketing, Quality, Production, and Supply Chain teams.
• Review and approve promotional materials from a regulatory perspective.
• Prepare, compile, and manage regulatory dossiers related to parapharmaceutical products.

Qualifications:

We are looking for candidates whose experience and skills align closely with the qualifications outlined below:

• Degree in Pharmacy, Master’s degree in Pharmaceutical Quality Assurance, Regulatory Affairs, or an equivalent scientific field.
• Minimum of 2 years of professional experience in Regulatory Affairs.

Skills

• Autonomy, proactivity, and a strong sense of responsibility.
• Strong analytical skills and attention to detail.
• Flexibility and adaptability.
• Team spirit and ability to collaborate effectively.