Global Regulatory Lead – Early Development Job in New Jersey (NJ), Regulatory Affairs Career, Jobs in Amicus Therapeutics
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Global Regulatory Lead – Early Development job in Cranbury

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Amicus Therapeutics jobs
New Jersey (NJ), Cranbury
Job Code:  498
Employer:  Amicus Therapeutics
Category:  Regulatory Affairs

Location
Country:  United States
State:  New Jersey (NJ)
City:  Cranbury
10/05/2018

Description


Global Regulatory Lead – Early Development Summary of Position
The Global Regulatory Lead (GRL) - Early Development works in coordination with Global Regulatory Affairs (GRA) management on the implementation of the global regulatory strategy for defined early development programs and products. The GRL acts as a primary interface that represents GRA as a member of core project teams, as well as, other functional matrix teams for assigned early development programs. The GRL presents the GRA perspective and defined strategy with team stakeholders, and works with functional groups to support coordinated global execution of the defined global strategic regulatory plan to bring innovative early development programs to patients with rare disease(s) in an expeditious manner.

Roles and Responsibilities
The Global Regulatory Lead (GRL) - Early Development is responsible for:

- Participate as GRA representative to product development teams, communicating regulatory requirements supporting global product approval for assigned program(s);
- Act as primary regulatory interface with FDA and/or other global regulatory agencies
- Act as the primary regulatory interface on the core project teams, as well as, other functional matrix teams to present GRA perspective to team stakeholders; the GRL will provide regulatory oversight to science, nonclinical, clinical and technical operations (CMC) aspects for global regulatory development for assigned early development program(s);
- Ensure regional engagement in corporate global regulatory functional groups and external resources (as required);
- Lead the GRA matrix team, including participation from key global regulatory functions as regulatory operations, medical writing, submissions, program management, as well as, representation from key functional representatives from product development teams, to communicate program regulatory status and requirements supporting global product approval for assigned program(s);
- Work with the International GRA team (including JPN, US, EU), to collaboratively prepare key deliverables supporting regulatory strategy execution for assigned program(s), including resolution of critical regional conflicts for a unified consensus global development program(s);
- In collaboration with core product development team, will develop a formal regulatory strategic operational plan, alternative plan(s) and mitigation strategy(ies) to address identified regulatory risks;
- Work collaboratively with the product development team lead and functional area representatives to provide strategic regulatory input to key development documents and study reports, as required, and ensure that key deliverables supporting regulatory strategy are provided in alignment with program timelines and management expectations;
- Provide direction to GRA leadership on program and proposed strategies as developed by the core project teams, as well as, other functional matrix teams, and provide regulatory assessment of proposed approaches according to established guidances and regulations;
- Ensure that new information (program, regulatory and/or intelligence) is appropriately reviewed by functional subject matter experts (SMEs), perform regulatory risk assessment(s) as required, and communicate proposed programs modifications and impact to the defined regulatory strategy to GRA leadership;
- Maintain consistent oversight of deliverables and ensure issues are escalated when needed and encourage resolution at the appropriate level. Play a key role in development and implementation of appropriate systems, processes and standards within GRA as assigned;
- Provide direction to Senior Leadership Team and Product Development Teams on emerging trends, regulations and changes, with emphasis on those related to assigned programs/ projects; provide assessments and feedback on new regulations and regulatory guidance, as requested.
- Reports to Director/Sr. Director, Global Regulatory Affairs

ref: (498)
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