Senior Regulatory AffairsPharmacistPermanent -Gauteng
Senior Regulatory AffairsPharmacistPermanent -Gauteng
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Senior Regulatory Affairs Pharmacist (Permanent) Gauteng
POSITION: Permanent
COMMENCEMENT: ASAP
PURPOSE OF POSITION: Medicines Registration and Maintenance of Product Licenses with various Health Authorities in various countries.
MINIMUM REQUIREMENTS:
- Bachelor of Pharmacy Degree
- Registered with the South African Pharmacy Council (SAPC).
- 1 2 Years experience in pharmaceutical regulatory affairs (SADC EAC preferred).
- Knowledge of relevant medicine legislation and guidelines.
- Ability to read regulatory authority guidelines assimilate and interpret this data to provide accurate succinct submissions.
- Ability to argue scientifically where sufficient justification exists to request exemption from certain requirements stated in guidelines.
- Computer literacy (MS Word Adobe Excel). Ability to produce high quality documents.
- Outstanding communication skills (verbal and written) fluent in English.
KEY PERFORMANCE AREAS:
- Submission of new pharmaceutical products for registration.
- Renewals of pharmaceutical products.
- Maintenance of registrations.
- Evaluate documents and complete a gap analysis.
- Compile the application for submission in accordance with the requirements prescribed by the Health Authority (HA).
- Attend to correspondence from the HA.
- Ensure product records/databases are updated in line with company requirements.
- Review of printed packaging for compliance with legislated requirements all affected markets.
- Review of marketing material in compliance with the marketing code and country specific regulatory requirements.
- Any other task relevant to the RA department as requested by management.
Competencies:
- Customer orientation
- Ability to meet deadlines & attention to detail
- Problem solving
- Assertiveness
- Business Competency
- Strategic Competency
- Leadership
- Professional
- Sense of Market and future trends
- Adaptability / Flexibility
- Planning / Organising
- Conflict Management
** Note: A Comprehensive list of all duties and responsibilities will be disclosed to / discussed with shortlisted candidates.
#pharma #pharmacist #pharmarecruitment #isanqajobs #isanqa #isanqaresourcing
iSanqa is your trusted Level 2 BEE recruitment partner dedicated to continuous improvement in delivering exceptional service. Specializing in seamless placements for permanent staff temporary resources and efficient contract management and billing facilitation iSanqa Resourcing is powered by a team of professionals with an outstanding track record. With over 100 years of combined experience we are committed to evolving our practices to ensure ongoing excellence.
Employment Type
Full Time
