Regulatory Affairs Specialist
- Post Date:July 24, 2023
- Views 1018
- Career Level SpecialistQualification DegreeExperience 1-3 Years
- Industry Health Care
The Group wishes to invite applications from suitably qualified & experienced individuals to fill in the Regulatory Affairs Specialist role that has arisen in our organisation.
- Participates in the implementation and development of the Regulatory Strategy.
- Develops and updates Standard Operating Procedures for registration of medicine with MCAZ in line with local and international legislature.
- Develops and updates the budget for product registrations consolidating inputs, requirements, and allied products from the relevant units.
- Assembles a regulatory file/dossier by coordinating the acquisition for all applicable data, assessed data and drafts.
- Verifies if collected data complies with current local and international legislature format.
- Analyses and verifies file contents.
- Conducts accurate assessments to anticipate questions and critical issues from the regulator.
- Submits the regulatory file to MCAZ.
- Updates clinical and pre-clinical data.
- Responds to questions from regulatory authorities.
- Conducts Regulatory monitoring of approved products.
- Monitors commitments/obligations in line with regulatory requirements.
- Assists and supports in house teams with compliance.
- Prepares Weekly and monthly reports.
- Degree in Science (Pharmacy, Pharmacology, Biochemistry) or related discipline.
- Certificate in Dossier assessments.
- At least 2 years experience.
- Master`s Degree in related discipline is an added advantage.
- Excellent verbal and written communication skills and an ability to prepare accurate reports.
- Ability to plan and organise in line with job requirements.
- Ability to analyse and solve work related problems while achieving the right outcome simultaneously.
- Ability to interact, negotiate (where applicable) and achieve targets.
If you are interested and you meet the stipulated requirements, please submit your letter of motivation and CV to this email [email protected] no later than Monday the 24th of July 2023.
Clearly highlight the position applied for in the email subject.