Regulatory Manager Intercontinental, Transverse
Il y a 7 mois
**Purpose of the position**
- ** Be responsible for Regulatory Submission and Life Cycle Management for assigned products and to identify and then communicate the implication of upcoming regulations that may impact the process. This also includes Geoexpansion and ESG projects.**:
- ** Develop and implement regulatory strategies for the assigned projects and it’s components for Intercontinental region.**:
- **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.**
**Main responsibilities and tasks**
- ** Overall Accountability**
Responsible for the development, flawless execution and implementation of regulatory strategies and submission activities for the assigned projects, transverse projects and new assets for Intercontinental countries, working with R&D, Franchise, Operations and within the GRSQ community to bring innovative and compliant approaches to the development and maintenance of assigned projects.
- ** Regulatory Submission**
- Responsible for the development and continuous adaptation of the regulatory submission for all assigned projects within the assigned portfolio.
- Drive Regulatory Activities in line with Ipsen guidelines on geo expansion in designated products, scope and countries.
- Close collaboration with both R&D and Commercial teams for ideal footprint and to comply with regulatory requirements of launching in Targeted Developing Markets
- Provide regulatory input including approval strategy into target countries (guidelines, submission pathways, country specific requirements, local legislation, and competition in identified target countries as applicable).
- 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.
- Support due diligence across regions within identified scope.
- To support transition and integration of new assets.
- Act as partner of Ipsen new asset integration team on behalf of Intercontinental Regulatory Affairs team.
- Provide regulatory input into the Integrated Development Plan. In collaboration with other Research & Development departments, define the optimal requirements to ensure dossier contains required data for successful submission and approval, reach the target product profile, taking into consideration the most favorable timing for all identified key developing markets.
- 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 through collaboration with local and intercontinental RA teams where available.
- Define and execute strategy for regulatory consultation (e.g. Scientific Advice, Health authorities 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.
- Contributes to process improvement initiatives on behalf of GRA.
- ** Regulatory Intelligence**:
- Responsible for continuously monitoring the scientific evolution in the assigned countries 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 strategy in relation to assigned products/disease areas.
- ** Communication**
Responsible for ensuring timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialisation teams, Public Affairs, Legal Investor Relations, etc.).
- ** Budget**
Contri
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