Regulatory Intern - MITG
PURPOSE:Working with the RA Specialist to provide assistance in the preparation of submissions to Regulatory bodies for initial registrations, variations and responses to queries to achieve approval.
ROLE OVERVIEW:Support regulatory objectives to ensure product meet SSA regulatory requirements for product approval.
MAIN JOB DUTIES/RESPONSIBILITIES
Regulatory Submission Support
- Work on Projects related to regulatory compliance in SSA.
- Participate in multidisciplinary project teams to present regulatory guidance and communicate regulatory goals.
- Assist with the organization of regulatory documents and correspondence
- Monitor newly published regulatory guidelines and guidance document on the context of new and ongoing development programs within SSA
- Communicate with regulatory bodies, health authorities and other stakeholders within SSA for assigned projects.
KNOWLEDGE/EDUCATION
- Undergraduate degree in pharmacy and related life sciences discipline is required.
- Excellent communication (written and verbal) and strong interpersonal skills.
- Results-driven; excellent attention to detail.
- Good problem-solving and analytical skills.
- Strong project management skills; able to manage multiple priorities.
- Ability to work independently.
- IT skills, particularly in relation to using databases.
SKILLS/COMPETENCIES
- Honest and ethical
- Must be computer literate at an intermediate level:
