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Senior Regulatory Affairs Manager
3 weeks ago
Gauteng, JHB - Eastern Suburbs
- Annually Cost To Company (Market related)
Well established Pharmaceutical business seeking to appoint a Senior Regulatory Affairs Manager
**Minimum Requirements**:
- B Pharm or Related Scientific Degree
- M Pharm an advantage but not a requirement
- Regulatory Affairs Pharma Industry
- 10+ years’ experience, of at least 5 years management experience
- SAPC Registered Pharmacist
**Key Knowledge and Skills required**:
- Relevant Acts, Regulations, and guidelines that governs the Pharmaceutical Industry
- Regulatory Authorities expertise and knowledge applicable to all RA aspects
- Knowledge of principles governing regulatory requirements such as ICH guidelines, WHO Prequal Evaluation requirements, EMA CMC, FDA SUPAC.
- Sense of urgency
- Proactive solution orientated, Logical thinking
- Attention to detail
- Communication skills
- Relationship building ability
- Team-working skills
- Knowledge of business unit plans
- Adapts to change easily
- Project Management skills
- Manages pressure appropriately
- Computer literacy (MS Office)
- For more information please contact:
- Mandy Scullard
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