GSK is one of the world’s leading research-based
pharmaceutical and healthcare companies.
We research, develop, produce and market vaccines and medicines to target unmet medical needs.
Our Consumer Healthcare business includes over-the-counter medicines, nutritional and oral healthcare products. Our business employs over 100,000 people across the world.
An exciting career opportunity has arisen for a highly motivated and enterprising individual to join our Consumer Healthcare Division as a Regulatory Affairs Manager.
Essential Job Responsibilities:
Translate the consumer business objectives into an actionable regulatory
affairs strategy so as to ensure that GSK standards in respect to regulatory
conformance and business continuity are maintained.We research, develop, produce and market vaccines and medicines to target unmet medical needs.
Our Consumer Healthcare business includes over-the-counter medicines, nutritional and oral healthcare products. Our business employs over 100,000 people across the world.
An exciting career opportunity has arisen for a highly motivated and enterprising individual to join our Consumer Healthcare Division as a Regulatory Affairs Manager.
Essential Job Responsibilities:
The key roles are as outlined below:
- Prepare
regulatory dossiers and correspondences, for new products and ensure that
the licences are maintained within East Africa.
- In
accordance with the business plan, conduct an assessment of which
countries are regulatory active and establish the regulatory requirements
based on the complexity of the individual markets.
- Manage
the relationship with regulatory authorities in East Africa on matters
relating to regulatory approvals for GSK Consumer products, respond to
queries and requests for additional information.
- Continuously
track and ensure product licenses within East Africa are maintained
through timely renewal, re-registration and submission of variations,
amendments and notifications.
- Establish
and maintain a document filing system to ensure easy access of documentation
and product history throughout the product life cycle and maintain
regulatory status reports of all regulatory active products.
- As
part of the New Product Introduction and New Product Development team,
align the regulatory registration submission strategy to commercial new
product introduction strategy in the relevant markets.
- Monitor
and report all adverse events and customer complaints reported for all
consumer products.
- Manage
Quality Management System Audits and tracks the implementation of audit
findings.
The successful candidate will have a minimum of a Bachelor’s Degree in Pharmacy with at least 5 years experience in Regulatory Affairs.
The candidate will have good communication and presentation skills, a team player with strong influencing skills.
He/She must be proficient in data base applications and a person of high level of integrity.
Interested candidates should apply stating their overall suitability for the position together with a detailed CV that clearly addresses the ability to perform the key responsibilities to: QYZ72406@gsk.com
The application deadline is 24th October 2011.
Kindly note that only shortlisted candidates will be contacted.
You can now click on this link www.kenyanvacancies.com to visit our sister website for more vacancies.
