Manager Regulatory Affairs Rare Diseases

Title:

Manager Regulatory Affairs Rare Diseases

Company:

Ipsen Innovation (SAS)

 

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:

Job Title:   Regulatory Manager, Therapeutic Area

Division / Function:  Research & Development, Global Regulatory Affairs (GRA)

Manager’s Job Title:  VP/Sr Dir/Dir, Global Regulatory Affairs, Therapeutic Area

Ipsen Job Profile:Regulatory TA

Location: R&D Hub (France, UK)

WHAT - Summary & Purpose of the Position

• To be 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.
• To 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 assigned product/project.
• To ensure the development and flawless execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) for assigned region or worldwide.
• 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 GRA

WHAT - Main Responsibilities & Technical Competencies

• Overall Accountability

Accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products.

• Product/Project Leadership

Accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs, either directly or through the supervision of the Regulatory Asset Team Member:

• Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics).
• Provide regulatory input into the Integrated Asset Strategic Plan. In collaboration with other departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets.
• Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with relevant functions and Asset Team/Sub-teams, ensure plan adaptation when needed. Assess impact on timelines. and/or label; proposes remediation where possible.
• With Asset Team/Sub-teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies. Establish optimal label with appropriate balance betwee