Responsible for managing Regulatory and Government Affairs by ensuring regulatory compliance to internal processes, policies, applicable laws, and regulations. In addition, provides and implements strategy related to regulatory and Government affairs stakeholders at the district/regional and national levels to the benefit of YBTC.
Management of YBTC regulatory issues including the provision of support on regulatory aspects of business issues, the proactive identification of prospective regulatory issues, defending penalties, stakeholder relationship management, input into regulatory policies/regulations, awareness, interpretation, legislative framework and future impact of new regulatory policies and legislation on YBTC operation
Support management on YBTC relationship, License management and fully compliance with regulations and country legislations and other supervisory functions / entities
Main Responsibilities
Develop and implement regulatory strategies for product registration and compliance.
Effectively engage with key stakeholders and decision makers in the executive and legislative arms of government
Establish, develop, and maintain effective corporate relationship with identified government stakeholders
Initiate and conduct regular meetings with key government stakeholders such as ,AFDA, MOPH, MoF etc. and provide advisory support on the same
Support management by preparing applications for products registration and custom clearance.
Prepare, review, and submit dossiers and documentation to AFDA and other national and international Should be familiar with Afghan Customs Department procedures such as custom clearance, import/export laws.
regulatory authorities.
Develop and maintain a strong ethical relationship between Company and the relevant institutions/ bodies with a view to ensuring the long-term viability of the business
Track and manage regulatory submissions and approvals, maintaining detailed records and timelines.
Track and maintain accurate records of all regulatory submissions and approvals.
Ensure timely registration, renewal, and variation submissions for product licenses.
Maintain up-to-date knowledge of evolving pharmaceutical regulations, standards, and guidelines.
Monitor, interpret, and communicate regulatory changes to internal stakeholders and guide implementation
Respond to regulatory inquiries and participate in audits and inspections.
Provide training and guidance on regulatory requirements to internal teams.
Coordinate with other departments during product registration.
Written reports as per the required formats set by the organizational requirements.
Organizational awareness
Knowledge of regulatory affairs
Having experience in administrative work
Analytical thinking and problem solving
Good negotiation skills
Business Administration or any other relevant field
Achievement and perseverance motivation
Flexibility and adaptability
Education
BBA,Pharmacy or Graduate of Law will be a plus point
Computer skills- proficient with office package
Excellent knowledge of English (Oral as well as written) Dari and Pashto.
Having at least 4-5 years relevant experience especially in Pharmaceutical company
Strong Dari and Pashto drafting skills
Please send your CV containing your cover letter that explains your suitability to the position at this stage certificates and other educational documents are not required
Clearly mention “Regulatory Affairs Officer” in your email subject line
Please note only short-listed candidates will be contacted for an interview.
Application received after deadline is not accepted
Yusra Bright is a leading pharmaceutical distributor in Afghanistan, dedicated to improving healthcare by providing high-quality, affordable medicines.
At Yusra Bright, we are more than just a distributor—we are a partner in building a healthier Afghanistan. By addressing key challenges in the healthcare supply chain and combating counterfeit medicines, we are committed to improving public health and enhancing the well-being of Afghan citizens. Through our unwavering dedication to excellence and innovation, we are making a real impact on the nation’s healthcare landscape.