Job Listing: Regulatory Affair Officer (3 Fresher Job Opportunities)
Organisation: Abacus Parenteral Drugs Limited (APDL)
Duty Station: Mukono, Uganda
About US:
Abacus Parenteral Drugs Limited (APDL) is a state-of-the-art manufacturing facility that seamlessly integrates hi-tech engineering services into the building design. From the exterior view, the 36-acre APDL campus exudes careful planning, and the interiors of the facility reveal thoughtful and spot-on detailing. The facility is designed with materials and finishes that allow ample natural light, thus conserving energy while maintaining high cleanliness standards and minimizing maintenance. The entire facility is designed to meet the CGMP requirements.
Job Summary:
We are seeking 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.
Key Duties and Responsibilities:
- Stay up-to-date on national and international regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
- Prepare and submit regulatory documentation, including applications for product registrations, marketing authorizations, and clinical trial approvals.
- Manage and maintain accurate records of all regulatory submissions, approvals, and correspondence.
- Liaise with regulatory authorities and respond to inquiries in a timely and professional manner.
- Analyze regulatory trends and their potential impact on the company’s products and operations.
- Participate in the development and implementation of regulatory strategies for new and existing products.
- Review and approve labeling and packaging materials for compliance with regulatory requirements.
- Participate in internal audits and ensure adherence to established regulatory procedures.
- Contribute to the continuous improvement of the company’s regulatory processes.
Qualifications, Skills, and Experience:
- The applicant must hold an Honors Bachelor’s degree in Pharmacy, Pharmaceutical sciences, Chemistry, or related field.
- Two years of progressive experience preferably in a busy pharmaceutical/healthcare industry.
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.
How to Apply:
All suitably qualified and interested candidates should submit their applications with updated CVs via email to apdlug.careers@abacuspharma.com
Deadline: 15th March 2024
