GSK (Regulatory Affairs Manager)

GSK- we are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of pharmaceuticals, vaccines and consumer healthcare. As one of the few healthcare companies researching both medicines and vaccines for the World Health Organization’s three priority diseases – HIV/AIDS, tuberculosis and malaria, we are very proud to have developed some of the leading global medicines in these fields.
Our product portfolio also includes a range of consumer brands, many of which are household names around the world, including Sensodyne, Aquafresh, Horlicks, Panadol and Tums.

Job Title: Regulatory Affairs Manager

Description

• To support the Head of Regulatory  in the implementation of  agreed regulatory strategy  as it relates to  registered products life cycle maintenance and  NCEs/NPDs and Branded generics registration in the market


• Work with the RAD to simplify and improve existing regulatory processes, systems and techniques to enhance capability of Regulatory Executives

Responsibilities

• Regulatory Due Diligence for successful NCEs/NPDs/PREPs registration 


• Clinical Trials Submissions and Tracking with Regulatory Agencies 


• OPAL Champion for (maintains updates and correctness of all approved  products  databases and Variations)


• Supervision of the REs to ensure deliverable are met yearly


• Agile MLCC for all products 


• IPI and PSUR updates handling


• Registered products Regulatory Databases maintenance /compliance


• Support the RAD in Regulatory Governance/Conformance Activities. E.g Project Edge Labeling


• Provide regulatory support as and when required for special projects


• Inter-phase with the Africa Regulatory Hub team on life cycle management processes


• External facing with Regulatory Agencies as back up for the Regulatory Affairs Director

Qualifications 

• Bachelor of Pharmacy degree/ BSc Biological Sciences


• PharmD, PhD  MBA, MSc, will be desirable

Location: Lagos 

Closing Date

Not Specified 

APPLY HERE 

NOTES

• GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 


• All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. 


• The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 


• In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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GSK (Regulatory Affairs Manager)