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Regulatory Affairs Pharmacist - South Africa
Posted on : 15 May 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Registration of new products and new indications
- Update and maintenance of existing products: technical modules and labeling updates to ensure compliance with local and global requirements.
- Due diligence of dossiers for new products and variation documents for existing products.
- Collaboration with at work co-ordinator to ensure compliance of printed packaging components
- Pro-active participation in discussions to update and maintain of Regulatory Affairs SOPs.
- Ensure departmental compliance with our company international and local policies and procedures
- For products in portfolio ensure that Regulatory Affairs databases are kept current .
- Active participation within subteams on RA projects .
- Active participation in meetings with internal and external customers as required
- B. Pharm Degree with registration as a pharmacist with the Pharmacy Council or similar (BSc in Life Science) and at least 2 years experience in a regulatory affairs environment in a multinational pharma company, preparing and submitting applications for registration of new products
- A proven track record of preparing and submitting technical and labelling updates (new indications and other amendments) for approval to ensure regulatory compliance of existing products
- Team player
- Ability to work to and meet deadlines
- Excel, Word and Powerpoint
- Ability to plan
- Thorough working knowledge of MCC Guidelines
- Basic knowledge of Medical Device Regulations
- Working knowledge of Marketing Code
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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