Director Regulatory Affairs Rare Diseases

**SUMMARY OF THE ROLE**
- 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 Regulatory Intelligence for relevant disease area 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 GRA

**MAIN RESPONSIBILITIES**

**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 within the assigned portfolio, either directly or through the supervision of the Regulatory Team:

- Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics).
- Provide regulatory input into the Integrated Development Plan. In collaboration with other Research & Development 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 R&D, Franchise, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; proposes remediation where possible.
- With R&D, Franchise, Operations and Project Teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies. Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes. Identify opportunities and limiting factors for optimal label and propose alternative solutions.
- Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels). Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics.
- With Franchise, contribute to the definition of the appropriate strategy for the assigned product.
- Consider regulatory avenues to maximize intellectual property protection and data exclusivity.
- In collaboration with other GMRS functions ensure the establishment of CCDS and required safety plans for the assigned product.
- Ensure regional regulatory specificities and needs are incorporated into the global plans though collaboration with local and intercontinental RA where available.
- Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards).
- Advocates to and seeks buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies.
- Responsible for ensuring potential risks have been identified and proactively proposing mitigation options for project team and senior management decision making.
- Accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes.
- Responsible for ensuring outsourced activities are delivered on time and on budget. Responsible for identifying and alerting management regarding any service issues.
- Review and input to all key documentation relevant to Franchise plans as required.
- Responsible for conducting regulatory due diligence assessment on external opportunities.
- Lead operational excellence initiatives within GRA.

**Regulatory Intelligence**
- Accountable for continuously monitoring the scientific evolution of the assigned diseases within the therapeutic area for its regulatory impact; incorporates externa