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Regulatory Affairs Manager Job in Kenya

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.

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.
Qualifications & Knowledge:

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.


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