Regulatory Manager

Job title: Regulatory Manager, Therapeutic Area

Department: Global Regulatory Affairs (GRA)

Line Manager (name, job title): Director/Sr Dir/VP Therapeutic Area Head, Global Regulatory Affairs

**Purpose of the position**
- ** Develop and implement regulatory strategies for the assigned projects and all its components for a major region or worldwide.**:

- **Be responsible for the strategy, and implementation of all regulatory aspects of the assigned projects and all of 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.**:

- ** Be responsible for Regulatory Intelligence for relevant disease area and to identify and then communicate the implication of upcoming trends that may impact the business.**

**Main responsibilities and tasks**
- ** Overall Accountability**

Responsible for the development, flawless execution, and implementation of regulatory strategies activities for the assigned projects for a major region or worldwide, working with R&D, Franchise, Operations and within the GRA community to bring innovative and compliant approaches to the development and maintenance of those products.
- ** Product/Project Leadership**
- Responsible for the development and continuous adaptation of the regulatory strategies for all assigned projects within the assigned portfolio:

- 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 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/project.
- Consider regulatory avenues to maximize intellectual property protection and data exclusivity.
- In collaboration with other 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).
- Responsible for ensuring potential risks have been identified and mitigation options proactively proposed 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.
- Contributes to process improvement initiatives on behalf of GRA.
- ** Regulatory Intelligence**
- Responsible for continuously monitoring the scientific evolution in the assigned disease areas for its regulatory impact; incorporates external environment into plans.
- Contributes to collecting, recording and sharing of competitive regulatory information for Ipsen competitor products.
- Contributes to monitoring the external environment to identify trends and assess potential impact on business and communicates this information to stakeholders in a timely and compelling way.
- ** Building Relationships with Regulators**

Contributes to building effective relationships with regulators for professional communications on Ipsen s