GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical, biologics, vaccines and consumer healthcare company which has its headquarters in Brentford, London. As of March 2014, it was the world's sixth-largest pharmaceutical company after Johnson & Johnson, Novartis, Hoffmann-La Roche, Pfizer, and Sanofi, measured by 2013 revenue. The company was established in 2000 by the merger of Glaxo Wellcome (formed from the acquisition of Wellcome plc by Glaxo plc) and SmithKline Beecham plc (formed from the merger of Beecham Group plc and SmithKline Beckman Corporation, which in turn was formed by combining the Smith, Kline & French and Beckman companies).
Job Title: Regulatory Affairs Manager
Requisition ID: WD91860
Requisition ID: WD91860
Basic qualifications:
Bachelor of Pharmacy degree/ BSc Biological Sciences
JOB REQUIREMENTS
MIN REQUIRED EXPERIENCE:
5 year(s)MIN QUALIFICATION:
Bachelor's Degree/HNDDESIRED COURSES:
Not SpecifiedOTHER REQUIREMENTS:
Preferred qualifications:
PharmD, PhD MBA, MSc, will be desirable
PharmD, PhD MBA, MSc, will be desirable
Details:
JOB PURPOSE
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
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
KEY 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 deliverables 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 Labelling
Provide regulatory support as and when required for special projects
Interphase with the Africa Regulatory Hub team on life cycle management processes
External facing with Regulatory Agencies as back up for the Regulatory Affairs Director
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 deliverables 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 Labelling
Provide regulatory support as and when required for special projects
Interphase with the Africa Regulatory Hub team on life cycle management processes
External facing with Regulatory Agencies as back up for the Regulatory Affairs Director
Important notice to Employment businesses/ Agencies
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.
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.
Interested candidates, follow link https://ngcareers.com/job/2016-10/regulatory-affairs-manager-at-glaxosmithkline-plc-gsk-941
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