Stresert Services Limited - Our client, one of the top three leading pharmaceutical companies in the country is in urgent need of a Drug & Regulatory Affairs Associate for a period of 6 months.
- To support the DRA Manager in registration of new drug products and the maintenance of registration of approved drug products in order to ensure viability of these products in the marketplace
- To support DRA Manager in ensuring the timely registration of new drug products and the maintenance of registration of approved drug products in order to ensure viability of these products in the marketplace as well as maintaining the DRAGON database to ensure up to 95% compliance level.
New Product Registrations:
- Support the DRA Manager by preparing local dossiers from the CTD for submission with drug registration applications in a timely manner and in follow up of the application during the evaluation phase to achieve a favourable outcome
Maintenance of registered products:
- Support the DRA Manager in maintaining registration of currently approved products
- Maintaining DRAGON database with up to date and accurate information of the products under the supervision of the DRA Manager
Relationship with Distributors:
- With minimum supervision, ensures all registration documents required for importation of products are provided to our distributors to ensure compliance.
Relationships outside the company:
- Develop and maintain good working relationships with Health Authority.
- Provide feedback from Health Authority to the DRA manger while following up on submissions made to the Health Authority.
Ethics and Compliance:
- Works within Ethics and Compliance policies and ensures those around him/her do the same
- Works to ensure a diverse and inclusive environment, free from all forms of dis-crimination and harassment
Key Performance Indicators
- The timely registration of new drug products and re-registration of approved products as at when due
- Accurate maintenance of registered products database.
- Achievement of over 95% of DRAGON compliance in updating it with normal country folder PDCs.
- Pharmacists with at least 5 years drug administration and regulatory experience are preferred
Method of Application
Interested and qualified candidates should forward all applications to: firstname.lastname@example.org using DRA and years of experience in drug administration and regulations as subject. e.g. "DRA-7 years". Only those who comply with this will be considered for the possibility of being invited.