Associate Director, Global Regulatory Affairs, Neuroscience

Title:

Associate Director, Global Regulatory Affairs, Neuroscience

Company:

Ipsen Bioscience, Inc.

Job Description:

The Associate Director, Global Regulatory Affairs, Neuroscience is accountable for the development, flawless execution and implementation of regulatory strategies and activities for the Neuroscience portfolio. The AD, GRA, Neuroscience will work cross functionally with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of our Neuroscience products.

Main Responsibilities

• Accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide.

• Provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects.

• Act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the Neuroscience portfolio

• Ensure the development and flawless execution of regulatory strategies for the Neuroscience portfolio and all of its components (both development and marketed products) globally

• Responsible for Regulatory Intelligence and to identify and then communicate the implication of upcoming trends that may impact the business.            

• Responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities or trade associations, particularly those that would benefit from a broad perspective on Ipsen regulatory policy.

• Lead operational excellence initiatives within Global Regulatory Affairs

• Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas.

• Ensure timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.).

Education, Experience and Qualifications

• BA/BS or equivalent in a scientific or related discipline is required; advanced degree is a plus

• Significant experience in the pharmaceutical industry, including at least 7+ years within Regulatory Affairs.

• Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.

• Track record of building excellent relationships with the FDA

• Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a strong plus.

• Knowledge of medical device / drug device combination regulations would be a plus.

• Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of agencies and ensuring compliance with regulations in all regions

• Ability to distil key information from complex and extensive sources and present the information in a constructive way.

• Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects.

• Consistent ability to foster strong matrix working with a proven track record of facilitating groups of individuals to work together on innovative regulatory solutions.

• Strong interpersonal and negotiation skills with a proven ability to build strong networks, both internally and externally  

• Proven capability to influence decision makers both internally and externally

• Proven ability to lead change and communicate difficult messages effectively

• Excellent written and oral communication skills and delivers all communication with clarity and impact.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.