GRA Expert

WHAT - Summary & Purpose of the Position

• 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 execute 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.
• Lead operational excellence initiatives within GRA

WHAT - Main Responsibilities & Technical Competencies

• Overall Accountability

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

o Implements regulatory strategy for specific projects under supervision of Therapeutic Area Senior Manager/Director/Senior Director.

o Contributes to the drafting of the regulatory strategy (Global Regulatory Strategy Document)

o Contributes to the data collection supporting building of the regulatory strategy (competitive and regulatory intelligence).

o Gathers, evaluates, organizes, manages and collates information for regulatory dossiers relating to development activities e.g. INDs/clinical trial applications, orphan drug designations, PIP/PSP submissions, NDA/MAA e.g. new and extension/variation etc o Contributes to review of regulatory dossiers.

o Ensures quality authoring of core administrative parts of submissions o Ensures adequate planning.

o Coordinates with Global Regulatory Affairs publishing team to ensure appropriate planning, completion of submission request forms, binder creation, publishing and submission (where relevant).

o Ensures that regulatory data are adequately reported and QC ed in the relevant tools / databases through data entry team in a timely fashion (eg Vreg) and that regulatory documentations are tracked/archived in dedicated tools / databases (eg eTMF) Uses a variety of specialist computer applications effectively.

o Ensures that quality and regulatory standards are met

• Operational excellence

o Supports operational excellence initiatives and diverse transversal projects within GRA.

o Contributes to the review of company systems and processes and is actively involved in the implementation of changes.

• Compliance

o Operates according to Regulatory and Ipsen SOPs.

• Reporting

o Ensures adequate reporting of his/her activities and participates to various meeting.

o Supports and voices the regulatory position consistent with the regulatory strategy validated by the management of the regulatory function.

• Ethics and Compliance

o Accountable for ensuring all activities are conducted in line with Ipsen's ethics and compliance policies

HOW - Knowledge & Experience

GRA Expert

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.

• First experience in Regulatory Affairs in the pharmaceutical industry or CRO (minimum of 3 years)
• Knowledge of regulatory procedures
• Excellent written and oral communication skills.
• Strong organizational skills.
• Strong interpersonal skills.
• Curiosity.
• Autonomy.