Working with the RA Specialist to provide assistancein the preparation of submissions to Regulatory bodies for initialregistrations, 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 communicateregulatory goals.
Assist with the organization of regulatory documents and correspondence
Monitor newly published regulatory guidelines and guidance document on the context of new andongoing development programs within SSA
Communicate with regulatory bodies, health authorities and other stakeholders within SSAfor assigned projects.
KNOWLEDGE / EDUCATION
Undergraduate degree in pharmacyand related life sciences discipline is required.
Excellent communication (writtenand verbal) and strong interpersonal skills.
Results-driven; excellentattention to detail.
Good problem-solving andanalytical skills.
Strong project managementskills; able to manage multiple priorities.
Ability to work independently.
IT skills, particularly in relation to usingdatabases.
SKILLS / COMPETENCIES
Must becomputer literate at an intermediate level :