Regulatory Specialist
He / she will report to the Global Regulatory Manager and will be based in Kenya.
The scope will include managing the interface between regulatory agencies at the country level and various business units in order to meet timelines and regulatory requirements; ensure successful registrations and regulatory approvals that are critical for timely product launches for the company’s financial success; provide direction, speed and knowledge for the company’s products registration on a regional basis.
The Regulatory Specialist is expected to:
The scope will include managing the interface between regulatory agencies at the country level and various business units in order to meet timelines and regulatory requirements; ensure successful registrations and regulatory approvals that are critical for timely product launches for the company’s financial success; provide direction, speed and knowledge for the company’s products registration on a regional basis.
The Regulatory Specialist is expected to:
- Define requirements to efficiently generate data packages for product chemistry, toxicology, environmental and product performance data necessary to receive approvals in a timely manner and meet sales objectives
- Keeping up to date with the company’s product range
- Record / registration document preparation for all authorities
- Maintain registration / renewal licenses by company, distributors, or agents in target countries
- Develop product and packaging labels in regional language specifications to ensure compliance; obtain approvals for these labels
- Material Safety Data Sheet (MSDS) translations to local languages for all products
- Responsible to ensure trademarks are registered in specified countries
- Interface with authorities through direct meetings and communications
- Liaising with and making presentations to regulatory authorities
- Contribute to annual budget for regional regulatory activities
- Know, interpret, and influence regulatory guidelines within region
- Maintain knowledge of permits and licenses necessary for import and export of products from countries in the region
- Communicate the impact of technical and regulatory issues on existing and potential market opportunities
- Outline complex regulatory options and make appropriate recommendations for action
- Work closely with the project managers, product teams within the various business units and Global Regulatory Manager to support projects to expand uses of current products
Essential skills include: extensive knowledge in developing protocols and analyzing data reports for registration requirements; capable of representing the interests of the company effectively to a range of regulatory agencies and government officials; have knowledge of registration requirements of target region; possess additional language skills.
Your application must include a covering letter highlighting relevant experience and key achievements, a detailed CV, a daytime phone contact, valid email address, and the names and telephone contacts of three professional referees.
Closing date: 1st April 2011
Only shortlisted candidates will be contacted
Adept Systems
Management Consultants
P O Box 6416, Nairobi, GPO 00100
e-mail: recruit@adeptsystems.co.ke
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