Full-Time Manager Regulatory Affairs
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Manager, Regulatory Affairs
This position will conduct the review of promotional and other materials, and the development and implementation of regulatory strategies for promotion and advertising plans. As the product expert, assists in the development and implementation of regulatory strategies for labeling, product defense, and development projects. Provide input into the global organization for labeling strategies of marketed drugs. Liaises with FDA.
Functions as the product expert for USRA issues
Oversee and bear responsibility for the successful implementation of regulatory tactical objectives and projects
Active participant and Regulatory representative on brand teams and in Review Committee
As a brand team member, provides proactive promotional strategies and tactics so that the company can meet both short and long term growth targets
Providing input to the Global organization on domestic regulatory strategies for in-line products
Ensuring optimal labeling on supplemental applications for labeling changes on in-line products
Provides product specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders
Manages relationships with FDA contacts; partners with Regulatory R&D to coordinate agency contacts and harmonize activities
• Bachelor’s Degree required
• Experience within pharmaceutical or medical device Regulatory Affairs
• Successful track record with ideally 3-7 years relevant regulatory experience.
• Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
• Knowledge and understanding of complex medical and scientific subject matter.
• Understanding of the U.S. pharmaceutical market place, and familiarity with medical terminology.
• Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Experience: 5 to 7 years