As a Global Regulatory Affairs Manager (Oral) your responsibilities will include the following:
· After discussions with Project Leaders/Teams, to issue a global regulatory clearance forecast for those countries in which the project will be launched. Accomplishing this will require considerable interaction with the global regulatory affairs network, in order to obtain up-to-date information on each country and region.
· To provide regulatory input, or to identify alternative reliable sources of regulatory input (in cases where expertise is not available internally) to category strategy in terms of both new product areas and the management of external issues impacting the category.
· Developing and maintaining excellent working relations with global project leaders, educating them on the value of involvement of Regulatory Affairs at all phases of the innovation funnel, but in particular at the concept stage.
· Constantly developing and managing a network of regulatory contacts around the globe. Establish an early warning system so that new regulations can be flagged and understood quickly, in order that the implications can be determined and communicated rapidly.
· To maintain excellent interfaces with amongst others: Safety, Legal, Public Affairs /External Affairs, Marketing Managers, Supply Management and senior leaders in order to meet the needs of Development programs and the Business.
Minimum BS in a science discipline, preferably an M.S. or PhD in Biological Science, Toxicology, Environmental Science or Chemistry or equivalent.
Significant experience and a proven track record operating in the areas of cosmetics, devices, medical devices and OTC drugs in the oral care product area.
Significant experience covering the development, research, and regulatory affairs functions and preferably a proven track record of working in an external environment (such as trade associations, Regulatory Authorities, etc.)
A working knowledge of the regulatory requirements that govern the cosmetic and device industry, preferably globally.
Excellent Communication Skills, both verbal and written, are essential. In addition excellent Interpersonal skills are a fundamental requirement of these roles. Contacts will include senior business leaders, developmentchemists, and marketing, legal, and regulatory affairs experts, so the ability to effectively communicate at all levels within the organization is required. Knowledge of formulation chemistry is needed to help determine how regulations will impact formulations.
REQUIRED LEADERSHIP BEHAVIOURS
Accountability & Responsibility
Consumer and Customer Focus
Bias for Action
Building Talent & Teams