Senior Regulatory Affairs Associate – MAAs
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Job Description
Senior Regulatory Affairs Associate managing post authorization submissions for healthcare solutions at Parexel. Ensuring compliance with local regulations through teamwork and document management.
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
Requirements:
- 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)
Benefits:
- Health insurance
- Professional development
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