As the leading medical recruitment agency in South Africa, our client has an exciting opportunity for a Regulatory Affairs Manager based in Cape Town, South Africa. The Regulatory Affairs Manager is to acquire and maintain all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. Supporting one or more products from a regional regulatory perspective Responsibilities:
Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products portfolio in compliance with global filing plans and local regulatory requirements.
Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Provide content guidance for regional regulatory documents and meetings in accordance with global company strategy
Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and etc.)
Support regional label negotiation activities
Under general supervision participate in the development, and execution of regional regulatory product strategies
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products
Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labeling
You will be joining the Multinational Medicine Regulatory team. You will be working with colleagues, who are responsible for leading the International regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.
This team leads the regulatory activities for established products and also development assets in the Oncology, AID & Orphan disease areas, as well as pre approval filing for Biosimilars & Generics.
Scientific Degree and demonstrated experience in a similar role
Min 5 years experience in similar role
Working with policies, procedures and SOPs
Knowledge of legislation and regulations relating to medicinal products
Awareness of the registration procedures in the region for clinical trials, MA, post approval changes, extensions and renewals.
Knowledge of drug development
Knowledge of and experience in regional regulatory environment
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
If this vacancy is closed or you have any questions, please contact email@example.com
Please be advised that you will be contacted by Medipath Healthcare Recruitment within 14 days should we wish to proceed with your application. Similarly, if you are not contacted by Medipath Healthcare Recruitment, please accept your application as unsuccessful. Your CV will automatically be added to our database and we could be contacting you should a suitable position arise.