Welcome, Guest: Register On Nairaland / LOGIN! / Trending / Recent / NewStats: 3,161,449 members, 7,846,884 topics. Date: Saturday, 01 June 2024 at 05:52 AM |
Nairaland Forum / Nairaland / General / Jobs/Vacancies / Vacancy For Regulatory Affairs Associate (204 Views)
Regulatory Affairs Associate / The Nigerian Electricity Regulatory Commission ("NERC") Aptitude Test / The Nigerian Electricity Regulatory Commission ("NERC") Is Recruiting. (2) (3) (4)
(1) (Reply)
Vacancy For Regulatory Affairs Associate by tolex29(f): 1:43pm On Aug 26, 2022 |
StreSERT Services Limited - We are recruiting on behalf of our client to fill the position below: Job Title: Regulatory Affairs Associate Location: Lagos Job Purpose Support EWA RA Team with life cycle maintenance activities in EWA Cluster Support EWA RA Team by preparing submissions for post-approval changes in EWA Cluster Follow up with the Health Authorities to achieve conclusion of submitted applications and escalate where necessary. Maintain all necessary company databases to ensure regulatory compliance at all times. Support RA managers by maintaining open communication with internal stakeholders such as NTO, CMC and the EWA RA Team as required and regularly provide feedback Major Accountabilities Prepare applications and ensure submissions for post-approval changes (variations, renewals) are made, and follow up with the Health Authority for timely approval. Maintain prompt submission of post approval commitments and other changes and provide timely responses to HA as required. Follow up with CMC and NTO for responses to deficiency letters received for submitted variations Maintain adherence to Global and local/regional processes with respect to life-cycle maintenance activities. Review the HA website regularly and ensure current information and updated guidelines are shared with the RA team and relevant regulatory databases are up-to-date and accurate Develop and maintain good working relationships with the Health Authorities, providing feedback from Health Authorities regarding submissions made or any relevant changes (processes, guidelines, etc.) Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner where necessary Ensure compliance to local and global KPIs Develop and maintain good working relationships with other organization functions/departments both locally and globally as well as with Health Authorities as required Support RA projects and activities as assigned by RA Managers & RA Specialist Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management. Key Performance Indicators (KPIs) Timely submission of post-approval changes (variations) and follows up with the Health Authority for approval. Ensure compliance with relevant Health authority guidelines and regulations Address issues related to compliance with urgency as appropriate Accurate monitoring and maintenance of relevant regulatory information management system(e.g. DRAGON, Production Transfer Tool) Achieve 95% Regulatory compliance deliverables (compliance with relevant databases, trainings and any such deliverable) Ideal Background Education (minimum/desirable): B. Pharm or BSc in life sciences Languages: Fluent in English (mandatory) Experience: 1-2 years RA experience Good communication and negotiation skills. Knowledge of CTD dossier format. Detail-oriented and organized Good team player Good inter-personal skills. Salary Very attractive Method of Application Applicants who meet the requirements listed above should forward their CVs to ‘outsourcing@stresert.com’ using position apply for as subject of the mail before 10th September, 2022 1 Like |
(1) (Reply)
1 / Exploit Limited: Get 20% Of Your Deposit Everyday / Jobhulu: Driver Needed Urgently (flyer)
(Go Up)
Sections: politics (1) business autos (1) jobs (1) career education (1) romance computers phones travel sports fashion health religion celebs tv-movies music-radio literature webmasters programming techmarket Links: (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Nairaland - Copyright © 2005 - 2024 Oluwaseun Osewa. All rights reserved. See How To Advertise. 9 |