Head of Regulatory Affairs

Overview

The successful candidate will lead the Regulatory Affairs team (excluding North America) with responsibility for the entire product portfolio (new products and existing (marketed) products) in all countries excluding North America. This is a critical role, with the successful candidate responsible for ensuring regulatory and certification activities are compliant to the relevant regulatory requirements worldwide

Main Activities

• Define & implement regulatory strategies and submissions for the company’s existing broad portfolio of products and for new products in the pipeline, supporting the company’s growth strategy
• Manage positive professional relationships with regulatory authorities, maintaining and improving Norbrook’s reputation with regulatory authorities (outside North Amercia)
• Lead the development/implementation of innovative strategies to maximise likelihood of regulatory success
• Lead the Regulatory Affairs Team with responsibility for all markets outside North America, driving productivity improvements/high standards of performance/challenging the status quo
• Ensure compliance with post-market approval regulatory obligations and maintenance of licenses/authorisations for existing products, including review/approval of internal specifications, evaluation of changes to determine impact
• Accountable for ensuring the company is updated on all relevant national and international legislation (outside North America), guidelines and regulatory practices ensuring compliancy
• Gain regulatory intelligence from global markets and share internally to develop best practice
• Identify continuous improvement within the regulatory team
• Act as lead Regulatory Affairs representative on the Change Control Board
• Oversee Regulatory evaluation of change controls, manage variation applications for existing products to ensure existing dossiers reflect current practice
• Ensure the Regulatory strategy for New Products supports rapid approval with advantageous labelling and successful commercialisation
• Participate in relevant Regulatory inspections
• Lead the preparatory activities for interactions with regulatory authorities, lead/co-lead face to face meetings and liaise/negotiate with international regulatory agencies
• Develop Risk Assessments/Action Plans based on regulatory agency outcomes

Essential Criteria:

Applicants must therefore demonstrate the following essential criteria on their application form in order to be considered:

• Educated to degree level in a relevant qualification, and/or minimum of 5 years’ experience in a regulated environment
• Demonstrable ability to lead a team, driving high standards of performance, developing talent/managing underperformance as required
• Minimum 15 years in a regulatory affairs management position, preferably within the pharmaceutical industry overseeing the regulatory approval of new and existing products in the UK/ Europe/Other Territories
• Excellent communication skills and ability to influence and develop positive stakeholder relationships.
• Ability to work cross-functionally, keeping all stakeholders informed of  regulatory changes and ensuring compliancy.
• Have a proactive/can-do attitude to be resolution driven.

Desirable Criteria:

Due to the nature of the role preference will be given to applicants demonstrating the following desirable criteria:

• Experience in animal health pharmaceutical sector
• Experience in a generics pharmaceutical company

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy we would particularly like to welcome applicants from the Protestant Community.

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