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Regulatory Affairs Specialist

2 months ago

Oklahoma City, Oklahoma, United States Hikma Pharmaceuticals Full time

Position:

Regulatory Affairs Specialist
Hikma Pharmaceuticals, a leader in the pharmaceutical industry, is dedicated to delivering accessible and high-quality medications to those in need. With a rich history spanning over four decades, we pride ourselves on our commitment to innovation and excellence in healthcare.

As we expand our operations, we are seeking a Regulatory Affairs Specialist to join our Regulatory Affairs New Submission Department. This role will be based on-site and is crucial for our ongoing success in the pharmaceutical sector.


Key Responsibilities:


1. Manage all pre-approval processes related to Marketing Authorization Applications (MAA) and Abbreviated New Drug Submissions (ANDSs), including addressing deficiency letters in accordance with regulatory standards.

2. Oversee all post-approval tasks concerning Abbreviated New Drug Applications (ANDAs), Marketing Authorization Applications (MAA), and related submissions, ensuring compliance with regulatory guidelines.

3. Assess Change Controls, issue/update New Registered Product forms (NRP's), and prepare variations in product information and labeling supplements.

4. Provide necessary documentation for Annual Product Reviews (APRs) and contribute to the creation and revision of internal Standard Operating Procedures (SOPs) and Design History Files (DHF) as required.

5. Support the introduction of new products by executing all regulatory activities necessary for successful launches.

6. Prepare, review, and implement labeling in compliance with established regulations.

7. Adhere to defined Key Performance Indicators (KPIs) to ensure departmental objectives are met.


Candidate Profile:
• A Master’s degree in Pharmaceutical Sciences is required.
• Experience in the EU market is preferred.
• A minimum of 4-6 years of relevant professional experience.
• Demonstrated responsibility, proactive approach, and ability to work collaboratively within a team.
• Strong awareness of regulatory guidelines and updates.
• Excellent organizational and planning skills.
• Ability to thrive under pressure and meet tight deadlines.
• Proficient analytical and negotiation skills.

What We Offer:
• Direct employment with Hikma Pharmaceuticals.
• Competitive salary commensurate with responsibilities.
• Comprehensive life and health insurance.
• Annual performance-based bonus.
• Significant opportunities for career advancement.

If you are looking to make a meaningful impact in the pharmaceutical industry, we invite you to explore this opportunity with us.