Regulatory Affairs Manager - LATAM
A global medical manufacturer is seeking a Regulatory Affairs Manager (LATAM). This role supports the Director in formulating and implementing regulatory strategies, managing the team, and ensuring compliance in the US, Canada, Latin America, and assigned Asian countries, in line with the goals of GCA companies and divisions (GCA, LATAM, GCOA, GCMA). The position reports to the Director of Regulatory Affairs and Product Engineering.
RESPONSIBILITIES
Regulatory Submissions and Compliance:
Prepare and review dossiers for regulatory submission, ensuring compliance with FDA, EPA, and LATAM regulations.
Collect and format documents for registering GC America products in Latin America and other regions.
Monitor and evaluate technical and scientific information for regulatory compliance, maintaining relevant regulatory lists for LATAM.
Team Management and Coordination:
Manage and evaluate the LATAM Regulatory Team, coordinating cross-functional teams and consultants.
Plan, organize, and lead projects, setting goals and motivating team members to achieve department and corporate objectives.
Organize and moderate weekly departmental meetings, tracking regulatory projects and tasks.
Documentation and Reporting:
Prepare, compile, and maintain pre-market and post-market documentation, including product registrations, technical files, and Safety Data Sheets.
Ensure timely support to LATAM countries, scheduling and prioritizing activities related to regulatory submissions.
Prepare responses to regulatory authority requests and support communication, tracking, and reporting of critical quality incidents.
Strategic Planning and Vendor Management:
Assist in budgeting, regulatory strategy, and goal setting, supporting the Director in vendor relationship management and evaluation of proposals.
Work with Legal to ensure NDAs with third parties are up to date.
Design strategies for compliance with new and existing regulations, communicating and motivating the team to achieve regulatory compliance.
Cross-Functional Collaboration:
Work with Product Engineering, Quality Assurance, Marketing, Product Management, and LATAM commercial sections on regulatory documentation and compliance.
Support requests from global GC entities, providing documentation and tests when required.
Participate in regulatory compliance activities, including quality audits, adverse event reporting, and adherence to Good Documentation Practices.
REQUIREMENTS
Bachelor’s Degree in a science field
Experience in a Regulatory Function in Pharma, Device or Healthcare
Experience in Management and Regulatory Affairs or Quality Assurance.
Multinational regulatory experience including North and Latin America, while not required, will be an advantage.
Managerial skills required. The ability to plan, coordinate, organize, work in teams, lead projects, and control costs are managerial skills the ideal candidate must possess.
Experience with FDA and Other Regulatory Authorities Required.
Ability to work across functions with Product Engineering, Quality Assurance, Marketing, Product Management and LATAM commercial section on regulatory requirements in assigned markets under the leadership of the Senior manager and the director.
Bilingual skills in one of these languages; Spanish, Portuguese, Japanese in addition to English
Microsoft Office Suite, Chemgees, Salesforce, SAP
SALARY& BENEFITS
$90,000-$120,000
Comprehensive health benefits and 401K
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