Senior Manager, Global Regulatory Affairs

Title:

Senior Manager, Global Regulatory Affairs

Company:

Ipsen Biopharmaceuticals Inc.

 

About Ipsen:

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!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Employer:                   Ipsen Biopharmaceuticals, Inc.  

Job Title:                     Senior Manager, Global Regulatory Affairs

Job Location:             Cambridge, Massachusetts

Job Type:                    Full Time

Duties:

• 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.

Requirements: 

Employer will accept a 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.

Position requires demonstrable experience in the following:

• 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.

Salary Range: $152,797 to $165,000.

Contact:     To Apply: e-mail resume to [email protected] referencing job 11926.64.1.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. 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.