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.