Job Description
To perform compliance tasks in accordance with the regulatory board and ensure that the organization is compliant
Duties and Responsibilities
1. Gathering, evaluating, organizing, managing and collating information provided by various departments to prepare regulatory filings to the regulatory board.
2. Obtaining Marketing Authorisation for the company’s products
3. Outlining requirements for product labelling, storage and packaging
4. Liaising and negotiating with regulatory authorities
5. Writing comprehensible, user-friendly, clear product information
6. Ensuring that quality standards are met and submissions meet strict deadlines
7. Working with API Suppliers and other vendors to address any deficiencies raised by Regulatory Authorities within prescribed timelines.
8. Continuous gathering of market intelligence that ensures the company stays ahead in terms of types of molecules filed, opportunities for faster registrations etc.
9. Ensuring there is a database of all Plant submissions made to the regulator indicating the status of each application.
10. Ensuring that products meet legislative requirements.
11. Ensuring compliance with regulations set by the regulatory board
12. Planning, undertaking and overseeing product trials and regulatory inspections
13. Offering advice about company policies, practices and systems
Qualifications and Experience
A first degree in Applied Chemistry/Bio-Chemistry with at least 2 years experience in in a similar position following through the listed duties.
Experience in the pharmaceutical manufacturing industry is an added advantage.
Must have great skills in communicating well and relationship management.
Should be very analytical and have a keen eye for details
How to Apply
Suitable and interested candidates to submit their CVs to pharmaceuticalrecruitments@gmail.com indicating the position in the subjectline.
