Regulatory Affairs Manager Latin America

Job Type: Location Type: Not Specified

 

The Regulatory Affairs Manager performs duties associated with the channel of information and creation/filing of regulatory documents required by GCA companies, divisions, departments (GCA, LATAM, GCOA, GCMA) to support company operations both domestic and globally to maximize revenue and profit.

Requirements

ESSENTIAL DUTIES and RESPONSIBILITIES:

• The position requires a basic understanding of chemistry, a Bachelor of science degree in a science field plus a minimum of 3 to 5 years’ experience with Regulatory Submissions and in a regulatory function in the Pharma, Device or Healthcare Industry. Regulatory experience in a multinational corporation with operations in 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, control costs are managerial skills the ideal candidate must possess.
• Management experience in managing small to mid-size teams with experience creating, motivating, leading, and evaluating the team to achieve department and corporate goals. The Manager works with the Senior Manager in budgeting, regulatory strategy, goal setting and motivation of team members and evaluates LATAM team members. Manages the LATAM Regulatory Team.
• Document collection across functions and departments for the purpose of registering GC America Products in the Latin American Region and any other assigned region according to the format required by each country.
• Prepare Dossiers for Regulatory submission, coordinate documentation formatting and maintenance within the documentation management system, maintenance of relevant regulatory lists for LATAM. Tracking documents, provision of timely support to LATAM countries, evaluating regulatory compliance and working with the team to maintain good relationships with regulatory partners, scheduling and prioritizing activities related to regulatory submissions.
• Proficiency in Microsoft office (Excel, Word, PowerPoint) is required and the ability to use ChemGes or similar database software to create SDSs will be an advantage.
• Evaluate available technical and scientific information for compliance with regulatory requirements and communicating per departmental processes and workflow.
• Responsible for operational Regulatory affairs activities, including coordination, preparation, and review of dossiers and documents.
• Knowledge of regulatory environment in any Latin American country or any assigned markets and communicate with the Team.
• Prepare, compile, format and maintain pre-market documentation required by assigned territories including product registrations, technical files, Safety Data Sheets Preparation, Complaints, etc.
• Working with relevant technical expert departments in cross functional teams requires interpersonal and communication skills. The ideal candidate should have excellent communication and interpersonal skills and be a good team player. The position requires the ideal candidate to work across functions with Product Engineering, Quality Assurance, Marketing, Product Management and LATAM commercial section on regulatory documentation, formatting, compliance, and activities in assigned markets under the leadership of the Senior manager and the Director of Regulatory Affairs.
• Work with product management, customer service, and other departments to prepare, compile and maintain post market documentation and resolve customer issues.
• Prepare adequate responses to regulatory authority requests in different Latin American countries to different regulatory authorities in collaboration with the LATAM and Regulatory Affairs Team.
• 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.
• Work with other GC Companies Regulatory Teams to support requests from global GC entities providing documentation such as BER, SER and other tests when required.
• Support communication, tracking and reporting of critical quality incidents as required.
• Uphold the principles and practices of the GQM business management system, including QC Thinking, Kaizen Innovation, and the corporate philosophy of GC no Kokoro.
• Participate in regulatory compliance activities related to the job function, including quality audits, adverse event reporting for GCA products, and adherence to Good Documentation Practices for reporting and record keeping.
• Perform other duties as may be assigned by the Regulatory Affairs Senior Manager and The Director of Regulatory Affairs from time to time.
• Ability to speak Spanish, Portuguese, Japanese while not REQUIRED will be an advantage for the ideal candidate.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in a science field
• 3 to 5 years in Management and Regulatory Experience in a Regulatory Function in Pharma, Device or Healthcare
• 3 to 5 years of 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.
• Ability to use Chemgees or another SDS database an advantage.
• Experience working across teams and functions in a multinational organization will be an advantage.
• 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.
• In addition to experience with FDA, prior experience working with COFEPRIS, ENVISION, and any other regulatory authority in Latin America, while NOT a requirement, will be an advantage for the ideal candidate. Bilingual skills in one of these languages; Spanish, Portuguese, Japanese in addition to English while not REQUIRED will be an advantage for the ideal candidate.
• Excellent communication and interpersonal skills. The successful candidate must have the ability to relate with and communicate with others respectfully in a team. Excellent interpersonal and communication skills are required for this position.
• Microsoft Office Suite, Chemgees, Salesforce, SAP