Multinational Pharmaceutical Company Regulatory Affairs Coordinator Job in Kenya

Regulatory Affairs Coordinator SSA (Sub Saharan Africa)
 

Location: Kenya
 

Industry: Pharmaceuticals
 

Our client, a multinational pharmaceutical company that specializes in the development and marketing of drugs for use in human medicine is seeking to recruit a Regulatory Affairs Coordinator. 

The ideal candidate will be required to develop and implement regulatory strategies to deliver timely submissions and approvals of key business assets.

 

Essential Job Responsibilities
 

Regulatory

• Develop and implement regulatory strategic programmes to drive speedy marketing authorizations for pharmaceutical products, including NCEs and line extensions/new indications, in alignment with market commercial objectives/priorities.


• Active involvement with regional project teams to improve internal processes.


• Support training and education programmes with local regulatory contacts/NSM (National sales managers), by organizing and chairing regional regulatory Meetings, to ensure understanding and compliance of company regulatory processes, including timely management of product updates. 


• Challenge unfavorable pharmaceutical legislation.   Network and establish influential relationships with national and/or international governments and trade associations, to achieve advantage for the organization and the industry by helping to shape the regulatory environment in the SSA Area.   This includes being involved in the Africa Regulatory Network (ARN), which comprises of regulatory managers from research based pharmaceutical companies.


• Actively and positively contributing to issue management as appropriate.


• Manage and Follow up the SSA regulatory expenses and budget with LOC’s (local Operating company)/META (Middle East Africa and Turkey)


• Manage SSA products licenses/authorizations update with META  interface


• Maintain an up to date SSA data base, with all regulatory guidelines, submission/GMP fees, approval timelines

Quality and others

• Coordinate with META, to implement quality processes to support the business activities, and be aligned with corporate (QMS) and local market policies.


• Coordinate all PV activities.


• Review of regional promotional materials.

Candidate Profile and Qualifications:

• A scientific background – degree and or higher degree in Medical / pharmaceutical sciences


• Experience and understanding of regulatory processes in the developed and developing world (Kenya, and some other SSA countries).


• Good understanding of technical and manufacturing issues


• Good commercial understanding and appreciation.


• Product knowledge across different therapeutic categories (pharmaceuticals, and generic molecules)


• Achievement, results driven


• Proven Communication, and negotiation Skills


• External Knowledge – products, therapy, environment, DRA


• Must be prepared to travel within territories in SSA.


• The incumbent should at least have 5 years’ experience of Research based Pharma Industry in Kenya or/and other SSA countries.


• Must be fluent in English, and Swahili.


• Knowledge of French will be a plus

To apply, send your CV and cover letter only to recruit@flexi-personnel.com before close of business 9th December, 2015. 

Clearly indicate the position applied for on the subject line.