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Regulatory Affairs Pharmacist Johannesburg South Africa,  

Posted on : 15 May 2017

Project Description

Regulatory Affairs Pharmacist-REG002538DescriptionMSD 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 in South Africa and Namibia.- Update and maintenance of existing products: technical modules and labelling 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 MSD 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 requiredQualifications- 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 CodeOur 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.Job: Regulatory Affairs Generic Job Title:Spclst, Regulatory AffairsPrimary Location: EMEA-South Africa-Gauteng-JohannesburgEmployee Status: RegularTravel: Yes, 10 % of the TimeNumber of Openings: 1Company Trade Name:MSD Job Segment: Regulatory Affairs, Pharmacy, Medical, Law, Compliance, Legal, Healthcare


Johannesburg ZA

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