Job Title: Regulatory Affairs Officer (3 Fresher Job Opportunities)
Organization: Abacus Parenteral Drugs Limited (APDL)
Duty Station: Mukono, Uganda

About Us:
Abacus Parenteral Drugs Limited (APDL) operates as a state-of-the-art manufacturing facility, seamlessly integrating hi-tech engineering services into its building design. With careful planning evident from the exterior, the 36-acre APDL campus showcases thoughtful and precise detailing within its interiors. Designed to allow ample natural light while conserving energy and maintaining high cleanliness standards, the facility meets CGMP requirements seamlessly.

Job Summary:
We are seeking highly motivated and detail-oriented Regulatory Officers to join our team. You will 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 promptly and professionally.
  • 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:

  • 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 detail
  • Good pharmaceutical knowledge
  • 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

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