Posts Tagged ‘Regulatory Affairs’

Flame Pharma is working alongside an international CRO in securing the services of the Head of Regulatory Development for their EMEA regions.  This strategic role will build and lead an industry leading regulatory function with an initial team of 20 +. 

As Head of Regulatory Development, your role will involve:

• Lead the Regulatory Development EMEA team’s development and implementation of global regulatory strategy for addressing client services across all regions.
• Provide strategic and operational leadership for regulatory enabling services for Clients /Sponsors Clinical Trial Applications and Marketing Applications, planning and preparing of quality submissions and preparing Clients for Boards of Health (BOH) interactions and meetings across all regions. This role is critical to the overall Company business, building additional Regulatory collaborative and Stand alone business and ensuring timely successful delivery of high quality services to the clients.
• Responsibility for all budgets and contracts in relation to the units projects and contact for the sponsor,
• Ensures globalization of processes. systems and initiatives as well as synergy in contribution from other regions while also encouraging, sharing and adopting best practices across the unit, GRD and GRA.
• With the evolving regulatory environment, brings sophistication, strategic regulatory intelligence and insight to the technical direction for the team in delivering client services, liaising with internal and external clients in the provision and marketing of these services, as well as in building relationships with the Board of Health (BOH) regulators.
• As the company expands its investment in Research and Global Product Development the group leader is expected to take innovative, value-added leadership to setting Regulatory affairs strategies, and develop the team’s capabilities in this area and other areas of talent development.
• The Regulatory Development EMEA Group Leader will have active participation in the GRD Leadership Team and other peer level stakeholder teams with strategic contribution to objective setting and achieving company goals.
• Success in this role will be achieved through continuing efforts to foster high quality regulatory services to client in new and existing business, build outstanding relationships with regulatory bodies worldwide and leading a world class regulatory organization to address the company’s business goals.

As Head of Regulatory Development, you will have the following skills and experience:
Broad regulatory affairs experience, strong Drugs, Biologics, vaccines development experience. Sound knowledge of Global Regulatory Procedures, including Clinical trials, marketing applications. Labeling Negotiation and product licensing. Proven success in agency influencing and negotiation. Good in-depth knowledge in one of the specialist areas; preclinical. CMC. Demonstrable management and leadership skills. Suitable level of experience within the Pharmaceutical industry with Regulatory Affairs and broad experience across product development