Regulatory Affairs Specialist
4 weeks ago
Job Description:
Ultra Personnel is seeking an experienced Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring timely initiation and management of the registration process for new product submissions, as well as ensuring approval of registration applications of all medicines with relevant authorities.
Key Responsibilities:
- Ensure timeous initiation and management of the registration process for new product submissions
- Ensure approval of registration applications of all medicines with the relevant authorities
- Complete specific pre-registration activities including receipt, screening, compilation, and submission of dossiers to regulatory authorities
- Ensure maintenance/update of registrations in accordance with relevant legislation, regulations, and guidelines
- Prepare and submit updates, variations, resolutions, and correspondence required by regulatory authorities
- Conduct dossier audits of registered products for assigned products
- Conduct dossier due-diligences, post-registration variations for all applicable regulatory authorities in compliance with latest regulatory guidelines and applicable regulations within specified time-lines
Requirements:
- Bachelor's Degree in Pharmacy
- Registered with the South African Pharmacy Council
- 1-2 years experience in Regulatory Affairs
- Experience in orthodox, human medicines is an advantage
- Demonstrable experience across product development, commercialization, and life-cycle maintenance
- Sound project management capabilities
- Proven ability to consistently deliver to quality, time, and cost standards
- Knowledge of new and emerging Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry
- Experience in use of CTD software builder and compilation of eCTD application will be an advantage such as docuBridge
Preferred Qualifications:
- Leadership skills
- Ability to prioritize and work to tight deadlines
- Cross-functional skills: Ability to network, liaise, and negotiate with others
- Problem-solving and decision-making skills
- Sound project management capabilities
Salary:
R550,000 - R700,000 per annum, depending on experience
Location:
Johannesburg or Cape Town
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