Title:  Officer, Regulatory Affairs

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people in need. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 1000 employees and 3 factories for the production of injectable medicines. 

Hikma, intends to recruit an Officer, Regulatory Affairs (m/f) to integrate Regulatory Affairs – Lifecycle Department, on-site work.

Main Responsibilities:

• Handling of all post-approval activities related to Abbreviated New Drug Applications (ANDAs) and Marketing Authorizations Applications (MAA), in specific, variations/supplements to current ANDA / MA, Annual Reports and replying to deficiency letters according to the regulatory guidelines.
• Evaluate Change Controls, prepare product information variations/labelling supplements, provide information for Annual Product Review (APRs), creation and revision of internal SOPs and DHFs whenever applicable.
• Support the site with the launch of new products, by performing all regulatory activities required.
• Prepare, review and implement labelling.
• Contact/support with all partners, suppliers, internal clients and Authorities.

Profile:

• Master’s degree in Pharmaceutical Sciences
• 0 – 2 years of Regulatory Affairs experience
• Fluency in English, as well as strong presentation and communication skills.
• Responsibility, proactivity and team work.
• Maintains awareness of regulatory guidelines and updates.
• Organization and planning capabilities.
• Ability to work under pressure and to meet deadlines.
• Good analytical and negotiation skills.

We offer:

• Direct contract with Hikma
• Salary appropriate to the functions performed
• Life insurance
• Health insurance
• Annual Performance Bonus
• High career prospects

If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day