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Regulatory Affairs Specialist
2 months ago
Position:
Regulatory Affairs Specialist
Hikma Pharmaceuticals, established over four decades ago, is dedicated to delivering accessible, high-quality medications to those in need.
With a strong foundation, we strive for daily innovation and practical solutions to enhance the lives of millions globally.
In the late 1980s, we expanded our operations beyond the Middle East, establishing a sterile manufacturing facility in Portugal for injectable pharmaceutical products, marking a significant milestone in our growth. Currently, we employ over 900 individuals across three factories in Portugal, focusing on the production of injectable medicines.
We are seeking a Regulatory Affairs Specialist (m/f) to join our Regulatory Affairs New Submission Department, with on-site responsibilities.
Key Responsibilities:
Manage all pre-approval processes associated with Marketing Authorization Applications (MAA) and Abbreviated New Drug Submissions (ANDSs), including responses to deficiency letters in accordance with regulatory standards.
Oversee all post-approval tasks related to Abbreviated New Drug Applications (ANDAs), Marketing Authorization Applications (MAA), Abbreviated New Drug Submissions (ANDSs), variations/supplements to existing ANDA/MA/ANDS, Annual Reports, and responses to deficiency letters as per regulatory guidelines.
Assess Change Controls, issue/update New Registered Product forms (NRP's), prepare product information variations/labeling supplements, contribute to Annual Product Reviews (APRs), and create or revise internal Standard Operating Procedures (SOPs) and Design History Files (DHF) as necessary.
Support the site in launching new products by executing all required regulatory activities.Prepare, review, and implement labeling.
Adhere to established Key Performance Indicators (KPIs).
Candidate Profile:
Master's degree in Pharmaceutical Sciences (minimum requirement).
Experience in the EU Market is preferred.
4-6 years of relevant professional experience.
Demonstrates responsibility, proactivity, and teamwork.
Maintains up-to-date knowledge of regulatory guidelines and changes.
Exhibits strong organizational and planning skills.
Ability to perform under pressure and meet deadlines.
Possesses good analytical and negotiation abilities.
What We Offer:
Direct employment with Hikma Pharmaceuticals.
Competitive salary commensurate with responsibilities.
Life and health insurance.
Annual performance-based bonus.
Significant career advancement opportunities.
If you believe this opportunity aligns with your professional aspirations, we welcome your interest in contributing to our mission of Better Health for all.
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