Senior Regulatory Affairs Associate (MAAs)
South Africa, Remote 职位编号 R0000039697 类别 Consulting关于这个职位
We are seeking a highly motivatedSenior Regulatory Affairs Associateto join our dynamic team. This role offers an exciting opportunity to work on post authorization regulatory submissions for the South African Health Products Regulatory Authority (SAHPRA), ensuring compliance with local requirements while contributing to the delivery of critical healthcare solutions.
As a Senior Regulatory Affairs Associate, you will work both independently and collaboratively within project teams, taking ownership of regulatory submissions from assessment through to Health Authority filing.
The role can be home or office based.
Key Responsibilities
Review and assess regulatory changes to confirm scope, impact, and submission requirements
Determine appropriate submission types in accordance with SAHPRA guidelines for CMC and Safety changes
Plan submissions by creating or confirming Submission Content Plans and required Submission Components
Request additional documents as required by Health Authorities
Compile and author local documents using approved templates and naming conventions
Complete all required internal reviews and approvals
Ensure Submission Content Plans reach approved state with all required documents included
Request necessary payments and coordinate publishing to enable Health Authority submission
Required Skills and Qualifications:
University Degree in a Scientific or Technical Discipline
Several years of experience in an industry-related environment
Knowledge of post authorization regulatory submission processes and requirements
Familiarity with SAHPRA guidelines
Awareness of CMC and Safety regulatory requirements
Strong teamwork and collaboration skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Proficiency in English (written and spoken)
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