Director, Regulatory Affairs

1 semana atrás

Sao Paulo, Brasil Edwards Lifesciences Tempo inteiro

Direct all Regulatory Affairs activities within the respective country(ies).

As Head of LATAM, Manage and oversee assigned Regulatory Affairs activities within Brazil, South Latin America and other Latin America Countries and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.

Identify risk, develop and lead in the implementation of broad and more complex regulatory affairs strategies within countries which may include negotiations with internal and external parties

Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues in collaboration with cross functional and/or matrix teams while ensuring regulatory compliance

Handle complex Regulatory Compliance issues and ensure these are communicated to the appropriate levels of the country, regional and functional management.
Analyze local regulatory trends and market intelligence information;
Advise and make recommendations to regional business organization and management on the potential opportunities, high impact risks of regulatory changes implementation;
Act as a strategic thought partner and the lead RA partner with stakeholders to develop the RA strategy to achieve its current and future business objectives.

Represent RA function through active participation at Country/Region Leadership Teams and Management reviews, grasping Business strategy and partnering with RA input.

This includes updating the BU & Marketing leaders, rCoE and RA Head on the New Product Introduction project, impact of product changes and license renewals timelines and status. Act as interface with Quality Assurance, RA Centre of Expertise and Business RA Leadership Teams for region and business of responsibility

Manage and submit local in-country Product & Clinical Trial Submissions when applicable. Lead Q&As with Local CA and strive to get early approvals. Obtain on time product approvals Managing Customer & Sales organization requests.

Build and maintain relationships and RA Agenda with local regulatory authorities and Advocate in National and Regional trade associations to gain market intelligence information; acts as a point of contact/Key Account manager for Local Competent Authorities, in both direct and indirect markets.

Develop RA relationship with Distributor RA counterparts. Supports Distributor RA activities. Educate Distributor on Edwards Standards

Develop and Manage regional/country team’s capabilities to support the business and region Provide input to AOP. Managers & Execute on approved Budget.

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