Regulatory Affairs Officer
Genix pharma
Total years of experience :2 years, 5 Months
Working as Senior Regulatory Affairs Officer, job description includes:
• Keep up to date with national guidelines approved by Drug Regulatory Authority of Pakistan and international legislation,
guidelines and customer practices from WHO.
• Possess a strong understanding of the registration procedures outlined by the FDA guidelines.
• Prompt preparation, which may involve authoring, and delivery of CMC contributions for regulatory submissions related
to medicinal products at all stages of their lifecycle. This includes supporting developmental programs, marketing
authorization applications, and post-approval activities.
• Responsible for providing CMC modules that are submission-ready to both internal and external regulatory stakeholders,
ensuring compliance with relevant systems and procedures, and maintaining submission quality.
• Write clear, accessible product labels and patient information leaflets.
• Work with the Artwork Coordinators to create/update and implement approved artwork mock-ups via the Electronic
Artwork Management System.
• Collect, collate and evaluate scientific data from a range of sources.
• Prepare submissions of Common Technical Documents.
• Ensure accurate regulatory records are kept. This includes:
• Maintaining and updating the electronic regulatory tracking database.
• Maintaining and updating the electronic document management system.
• Inputting and retrieving information from the electronic quality management system as required.
• Ensuring the paper and electronic filing is kept up to date.
• Management of the external archiving of regulatory documentation.
• Review company practices and provide advice to Quality Departments.
• Collaborate with regulatory authorities and deliver presentations as needed to ensure effective communication and
compliance with regulations.
• Participate in the development of marketing concepts and oversee the approval process for packaging and advertising
materials to ensure compliance and alignment with regulatory standards before the product's release.
• Proficient in project management, adept at adapting to dynamic circumstances to ensure timely project delivery.
• Keep the Regulatory Affairs Manager informed about completed activities and upcoming projects on a regular basis.
Additionally, actively participate in monthly Medical Meetings to contribute insights and updates relevant to regulatory
affairs.
• Advise Quality and manufacturing departments on regulatory requirements.
• Registration of medicinal products in different countries and territories for example
Iraq, Ivory Coast, Senegal, Qatar, Kuwait, Afghanistan, Congo, Cambodia, Moldova
Guatemala, Rwanda.
• Address inquiries from medical bodies such as the AIRP, NAFDAC, Ministry of Health of the Republic of Moldova, and
IMMDA (Iraq) promptly and accurately, ensuring clear communication and compliance with regulatory requirements.
Worked as Production Officer in Semi-solid Department:
• Responsible for various document control BPR, BMR and their audit.
• Reconciliation of documents, material control and calculation, loss of material and reporting to management regarding
Batch Yield.
• Implementation Good manufacturing practices within the production premises, flow of material interaction with workers
and following SOPs for better line management and results
• Performed line clearance in start of batch, In process control checks during batch running, Major or minor cleaning after
batch completion.