Senior Manager, Global Regulatory Affairs

Ipsen • Cambridge, MA

15d

About The Position

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

Requirements

• Master's degree in advanced scientific discipline, biology, pharmaceutical science or related field and 2 years of experience in the job offered or in a Senior Manager, Global Regulatory Affairs-related occupation.
• Prior work in the Neuroscience therapeutic area, including Toxins.
• Professional background in the pharmaceutical industry, including Global Drug Development Regulatory Affairs.
• Proven track record in managing regulatory affairs filings and regulatory process management, including US IND submissions and CTAs across several European countries.
• Leading meetings with global regulatory agencies including Europe
• Familiarity with using Veeva Vault.
• Background working with US and global teams cross-functionally across different geographies to facilitate regulatory solutions.
• Strong knowledge of EU and US pharmaceutical regulations and/or requirements for global markets.
• Skilled in identifying regulatory filing risks in advance and developing creative solutions using knowledge of agency regulations to meet expectations and ensure compliance across all regions.

Responsibilities

• Develop and implement regulatory strategies for the assigned projects and all its components for a major region or worldwide.
• Responsible for the strategy, tactics and implementation of all regulatory aspects of the assigned projects and all its components for a major region or worldwide.
• Provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned 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 assigned project.
• Responsible for Regulatory Intelligence for relevant disease area and to identify and then communicate the implication of upcoming trends that may impact the business.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level