Specialist, Regulatory Affairs
3 meses atrás
Founded in Jordan more than 40 years ago by Samih Darwazah, Hikma's purpose is to provide affordable, quality medicines to the people needing it. 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.
Hikma is a multinational company with 31 plants located in Europe, US, Middle Est and North Africa.
The site in Portugal, has 1000 employees and 4 plants for the production of injectable medicines.
Hikma, intends to recruit a Specialist, Regulatory Affairs (m/f) to integrate Regulatory Department , on-site work.
Main Responsibilities:
Handling of all post-approval activities related to Abbreviated New Drug Applications (ANDAs) Marketing Authorizations Applications (MAA), Abbreviated New Drug Submissions (ANDSs), variations/supplements to current ANDA / MA / ANDS, Annual Reports and replying to deficiency letters according to the regulatory guidelines Evaluate Change Controls, issue/update New Registered Product form (NRP's), 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 on the launch of new products, by performing all regulatory activities required Prepare, review and implement labelling Comply with the defined KPlsProfile:
Master’s degree in Pharmaceutical Sciences (Minimum) Experienced in EU Market Regulatory Affairs (Preferred) 4-6 years of professional experience 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 skillsWe offer:
Direct contract with Hikma Salary adequate to the function and experience Life insurance Health insurance Annual Performance BonusIf you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day
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