_edited.png){kind=small}
Share this Job:
Regulatory Affairs and Compliance Officer job at Abacus Pharma (A) Ltd | Apply Now
Are you looking for Medical jobs in Uganda 2024? If yes, then you might be interested in Regulatory Affairs and Compliance Officer job at Abacus Pharma (A) Ltd
Kigali, Rwanda
Full-time
Deadline:
April 30, 2024 at 2:00:00 PM
About the Organisation
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, 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 and still maintain high cleanliness standards and minimize maintenance. The entire facility is designed to meet the CGMP requirements.
.jpg)
Job Title
Regulatory Affairs and Compliance Officer job at Abacus Pharma (A) Ltd
Job Description
Abacus Pharma (A) Ltd – Rwanda, is looking for a skilled and experienced Regulatory Affairs and Compliance Officer to join our dynamic team. As a Regulatory Affairs and Compliance Officer, you will play a pivotal role in ensuring adherence to regulatory standards and compliance with quality assurance systems. Key responsibilities include overseeing product pre-registration, registration, and post-registration processes, providing effective and efficient quality assurance systems support to Abacus Rwanda, including supporting the implementation and maintenance of the quality management system, and performing the day-to-day work to meet the compliance standards of the QMS and the local Regulator as applicable to global and local standards
Duties and Responsibilities
Dossier review
Review and evaluate documentation of drugs, medical devices and cosmetics before submission of dossier to RFDA for registration.
Communicate with applicant/ manufacturer on the requirements/ deficiency of the dossier before submission of the application for registration of the products to RFDA.
Compilation of dossier after submission of information from applicant/ manufacturer and approve submission of dossier to RFDA for application of registration of product.
Registration Process
Cooperate with the company finance department to ensure that all fees relating to drug registration are payable to RDFA.
Submission of dossier, samples and other requirements to RFDA for application of product registration of products.
Submission of GMP documents, i.e. SMF, to the Authority for the site audit and coordinating with the Authority for the audit plans.
Make a close follow-up on the application of registration of the product and facilitate the registration process by responding to queries addressed by RFDA on time.
Collect and confirm the registration certificate granted by RFDA after registration approval.
Registration
Importation of product
Importation process of the product by applying for a permit for importation of the product (RFDA online application system).
Monitor storage of products under respective storage conditions at the premises.
Post Registration.
Post-marketing surveillance and Pharmacovigilance
Take measures by reporting to RFDA on any issue relating to counterfeit drugs and substandard drugs identified on the market.
Collection of information relating to adverse drug reactions and report to RFDA.
Coordination of the recall process of any product complaints from customers and take necessary measures.
Post Approval regulatory issues.
Application of post-approval regulatory issues such as variation/ alteration, promotional materials approval and renewal of the registered product
Coordinating the payment of the annual retention fees for the principal companies
Renewal application of product registered after expiration of registration time
Apply for any variation as per company and market interest.
Applying for the approval of the promotional material
Destruction Process
Coordinating of the destruction process for expired/damaged/recalled products.
.jpeg)
Qualifications and Competencies
Technical Knowledge/ Skills:
Excellent written and verbal communication skills
Analytical mindset and problem-solving skills
Ability to work independently and in cross-functional teams
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
Behavioral / Attitude Competencies:
Respect for others
Sociability
Result-oriented
Openness and decisiveness
Teamwork
Minimum Qualifications
Bachelor’s degree in Pharmacy
3 years of experience in the pharmaceutical or healthcare industry
How to Apply
Send your CV and academic credentials to : aplrw.rwanda@abacuspharma.com
PRO CV WRITER
Increase your chances of getting hired with the perfect resume
Let us help you create a perfect CV and Cover Letter!
30% higher chance of getting a job
42% higher response rate from recruiter
Related Jobs
You may also Like!
