3 Regulatory Affair Officers
Abacus Pharma (A) Ltd
Supply Chain & Procurement
Job Summary
We are seeking a highly motivated and detail-oriented Regulatory Officer(s) to join our team and play a vital role in ensuring the company’s compliance with all applicable regulations governing the development, manufacturing, and marketing of pharmaceutical products.
- Minimum Qualification: Bachelors
- Experience Level: Entry level
- Experience Length: 2 years
Job Description/Requirements
Number of Positions: 03
Job Location: Mukono
Job Category: Full-time
Job summary
We are seeking a highly motivated and detail-oriented Regulatory Officer(s) to join our team and play a vital role in ensuring the company’s compliance with all applicable regulations governing the development, manufacturing, and marketing of pharmaceutical products.
Job Description
1. Stay up-to-date on national and international regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
2. Prepare and submit regulatory documentation, including applications for product registrations, marketing authorizations, and clinical trial approvals.
3. Manage and maintain accurate records of all regulatory submissions, approvals, and correspondence.
4. Liaise with regulatory authorities and respond to inquiries in a timely and professional manner.
5. Analyze regulatory trends and their potential impact on the company’s products and operations.
6. Participate in the development and implementation of regulatory strategies for new and existing products.
7. Review and approve labeling and packaging materials for compliance with regulatory requirements.
8. Participate in internal audits and ensure adherence to established regulatory procedures.
9. Contribute to the continuous improvement of the company’s regulatory processes.
COMPETENCIES:
Technical Knowledge/ Skills:
Attention to details,
overall good pharmaceutical knowledge,
endeavor for learning and logical explanation to queries
Analytical Skills
Computer Skills (PPt, Excel, MS Word and Adobe Acrobat)
Behavioral/Attitude Competencies
• Time management skills
• Problem-solving skills
• Presentation skills
• Communication skills
• Innovative/creative skills.
Minimum Qualifications / Requirements:
• Honors Bachelor’s degree in Pharmacy, Pharmaceutical sciences, Chemistry, or related field.
• 2 years of progressive experience preferably in a busy pharmaceutical/healthcare industry.
Application procedure
For the Job Application process: send your Academic Credential and CV before 15th. 03.2024 to: apdlug.careers@abacuspharma.com
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