Company: TEC Group International
Reference: SAM BEG
Closing Date: 18 Dec 16
Type: Full Time
Salary (£): 80,000 - 100,000
For more information or to apply for the position please contact Sam Murphy at the TEC Group International. 0208 544 3224 / firstname.lastname@example.org
The Regulatory Lead is the regulatory scientific expert and a standing member of assigned compound development project teams. In this role, the Regulatory Lead delivers the regulatory strategy and executes this strategy upon endorsement by the project team, in an effective and compliant manner throughout all phases of development.
· Obtain and maintain regulatory approvals for the company’s products.
· Regulatory expert for assigned compounds, provide regulatory scientific and strategic guidance for effective and compliant compound development.
· Implement and execute the regulatory strategy endorsed by the project team.
· Ensure full compliance with all applicable regulations and ensure this is reflected in the company processes.
· Act as company representative towards health authorities. Profile Education University degree in health sciences, pharmacy, biological science, chemistry or related field.
• At least 10 years of relevant experience in a broad range of regulatory affairs projects in the Pharmaceutical/biotech industry and/or with regulatory authorities.
• A profound and demonstrated knowledge of the international regulatory affairs environment with a sound understanding of the pharmaceutical/biotech business-environment
• Previous experience in an international context or in an alliance or collaborative product development setting with an external partner is desirable.
• Previous experience in the development of fixed-dose combination products is an advantage. General Skills
• Demonstrated ability to manage multiple tasks/projects/priorities and complex issues. Demonstrated attitude of reliability and attention to detail.
• Team player with a professional attitude towards external and internal contacts.
• A high degree of flexibility, resilience, and assertiveness are essential for success. Communication Skills
• Strong verbal and written communicator in English language, multilingual is an asset.
• Diplomatic attitude with excellent negotiation skills allowing reaching a consensus between different stakeholders.
Dowgate Hill House, 14-16 Dowgate Hill, London
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