Compliance Officer and Project Manager-Regulatory Affairs

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Career Opportunities

Our client is one of the world's leading research-based pharmaceutical and healthcare companies. It is committed to improving the quality of human life and registered in about 120 countries across Europe, America, Africa, Asia, Middle-East and the Caribbean. The company is offering you a great opportunity to be part of its high calibre and dedicated professionals in Africa, to improve the quality of life in our sub-region.

COMPLIANCE OFFICER
Reports to the Area Director - Africa

Key Responsibilities
Act as source of expert knowledge of the company's compliance programmes and their implementation to AFRICA's operating units
Update knowledge through on-the-job activities and participation in specialist development programmes and support the development of an effective and pragmatic compliance culture in AFRICA
Ensure a sound system of internal controls and legal compliance within AFRICA in line with corporate and EM Pharmaceutical
requirements
Provide leadership on Compliance issues to Operation Unit Compliance Champions and proactively identify emerging risk areas for
AFRICA
Provide input to the annual and ongoing Compliance objectives for AFRICA and functional management based on direction provided by Regional Management
Chair the AFRICA Risk Management and Compliance Board (RMCB), set the meeting agenda and maintain appropriate records
Report risk issues and best practice identified at Area RMCB as required to the International Region
Ensure confidential internal reporting processes and reported concerns are correctly and promptly investigated
Implement effective processes to investigate identified instances of nocompliance or misconduct
Review audit findings with line management and ensure compliance with
all relevant data protection / data privacy laws across AFRICA
Ensure proper record keeping in respect of all compliance requirements in AFRICA, track and report on progress as required
Provide input on behalf of AFRICA and propose changes to Compliance
programmes to ensure due respect is given to prevailing local requirements, culture and practice

Educational Qualifications/ Experience
Must have a first degree and any professionally recognised qualification in Finance, Legal, Business Administration,
Engineering, Medicine
Experience in a compliance role or its equivalent

Essential Skills, Knowledge and Abilities
Quality leadership skills
Ability to harness the commitment and contribution of team members outside of direct span of control
Good understanding of business processes and how they integrate at entity level


PROJECT MANAGER-REGULATORY AFFAIRS
Reports to the Regulatory Affairs Director-Africa

Key Responsibilities
Plan, manage and track technical variations, label changes and renewals/ reregistrations with Operating Units
Track regulatory deliverables using appropriate tools and present a monthly progress report
Ensure alignment between area/region and country strategies for regulatory submissions
Be responsible for a group of products across a franchise or a subset of a franchise and maintain close contacts with the country regulatory managers to ensure that shared objectives are achieved
Co-ordinate and provide support for preparation and dispatch of relevant dossiers for assigned franchise
Identify key issues on resource or registration activities that could prevent achieving objectives and pro-actively propose solutions to manager
Exhibit a solid understanding of the African regulatory legislation, particularly relating to administrative and procedural aspects
Participate in the development of Standard Operating Procedures and guidelines

Educational Qualifications / Experience
A first degree in Pharmacy or life Science or biomedical science
A minimum of 5 years experience in the pharmaceutical industry, which
must include at least 3-4 years Regulatory Affairs experience

Essential Skills, Knowledge and Abilities
Knowledge of Regulatory legislation in at least one geographic area in Sub-Saharan Africa
Knowledge of Pharmaceutical / Biological / Vaccines
A working knowledge of Excel, MS Project and Power point
Very fluent in spoken and written in English. French language proficiency will be an advantage

Interested applicants should please apply with their CVs by 25 February 2011 to:
HR Advisory Services
KPMG
Marlin House
13 Yiyiwa Drive
Abelenkpe
P.O. Box P 242
Accra

Or by e-mail to hr@kpmg.com.gh

Only short-listed candidates will be contacted.

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