537 Pharma Medical Devices in Minas Gerais lowest at $2400.0+

Senior Regulatory Affairs Analyst – Drug Registration64845061792258120

Indeed

Senior Regulatory Affairs Analyst – Drug Registration

Job Description: Education* Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or related fields. Experience * Experience in Regulatory Affairs. Knowledge * ANVISA legislation and oversight; * Regulatory requirements for product registration and post-registration; * Good Manufacturing Practices (GMP); * Product registration approval; * Intermediate Microsoft Office Suite; * Analyze, develop strategies, monitor, and prepare dossiers for submission, in accordance with current legislation; * Monitor current legislation and assess its impact on departmental processes, implementing necessary adjustments and actions; * Monitor legislation applicable to drugs in general, health products, food, cosmetics, and active pharmaceutical ingredients (APIs); * Evaluate, design, and implement regulatory strategies for necessary changes throughout the product lifecycle and projects; * Develop strategies and guide responses to defined regulatory requirements; * Understand the implications of different solutions for each project, analyzing business needs, customer demands, and organizational impacts; * Receive and review outcomes from process development, deliberations, meetings, and required information; * Responsible for identifying, analyzing, and interpreting drug registration records; * Ensure accurate completion and updating of local and global databases, and maintain proper organization of physical and electronic files within the department to preserve a complete historical record of all processes; * Communicate with and draft responses to regulatory requests issued by authorities; * Issue sanitary certificates through the National Health Surveillance Agency (ANVISA), via its validated website, email, and/or direct contact with federal inspectors, ensuring inclusion of relevant declarations accompanying certificate issuance and validation; * Verify documents supporting product traceability—including sales invoices, analytical test reports, and other documents that may constitute submissions for Clinical Development Dossiers for Drugs (DDCM) and Specific Trial Dossiers, as stipulated by current legislation; * Monitor changes in legislation relevant to the Organization’s operations, assess their impact on departmental processes, and develop necessary adjustments and actions to meet operational demands; * Analyze and organize documentation required for registration and launch of new products, following instructions from immediate supervisors and applicable regulatory guidelines, aiming for approval by competent authorities; * Occasionally organize documentation for product registration, renewal, modification, and post-registration with regulatory agencies, preparing reports per applicable regulations to comply with legal requirements; * Analyze, review, and stay updated on ANVISA legislation, regulatory norms, ordinances, and updates to ensure Pharlab’s activities and commercialization in the market remain compliant. 2512170202551884724

R. Joaquim Gomes Pereira, 854 - Lagoa da Prata, MG, 35590-000, Brazil

Negotiable Salary

Senior Regulatory Affairs Analyst - Medicines Registration64559518045954121

Indeed

Senior Regulatory Affairs Analyst - Medicines Registration

We are seeking a professional with extensive experience in **Regulatory Affairs** to analyze, develop strategy, monitor, and prepare dossiers for submission, considering current legislation. Analyze projects and execute regulatory strategies for changes during the product lifecycle and projects, ensuring correct completion and updating of databases, as well as ensuring proper organization of physical and electronic files to maintain a complete process history. Responsible for identifying, analyzing, and interpreting medicine registrations. Understand the impacts of different solutions, balancing business needs, customer demands, and organizational implications. We offer an opportunity for a **Senior Regulatory Affairs Analyst**. **Responsibilities and duties** * Analyze, develop strategy, monitor, and prepare dossiers for submission, considering current legislation; * Monitor current legislation and analyze its impact on departmental processes, developing necessary adjustments and actions; * Monitor regulations for medicines in general, health products, food, cosmetics, and APIs; * Evaluate, plan, and execute regulatory strategies for necessary changes during the product lifecycle and projects; * Develop strategy and guide responses to projected requirements; * Understand the impacts of different solutions for each project, analyzing business needs, customer demands, and organizational implications; * Receive and review results from process development, leading meetings and gathering necessary information; * Responsible for identifying, analyzing, and interpreting medicine registrations; * Ensure accurate completion and updating of local and global databases and ensure organization of physical and electronic files within the department to maintain a complete process history; * Communicate and prepare responses to regulatory requests issued by authorities; * Issue sanitary certificates through the National Health Surveillance Agency (Anvisa), via validated website, email, and/or contact with Federal Inspectors, monitoring the inclusion of relevant declarations accompanying certificate issuance and validation; * Review documents comprising product traceability, sales invoices, analysis reports, and other documents that may be included in submissions for Clinical Development Dossiers for Medicines (DDCM) and Specific Trial Dossiers, according to current legislation; * Monitor changes in legislation relevant to the organization's operations, analyzing their impact on departmental processes and developing necessary adjustments and actions to meet demands; * Analyze and organize documentation required for registration and launch of new products according to immediate supervisor guidelines and regulatory data, aiming for approval by competent authorities; * Occasionally organize documentation for registration, renewal, modification, and post-registration of products with regulatory agencies, preparing reports according to regulations to comply with legal requirements; * Analyze, review, and stay informed about Anvisa legislation, regulations, directives, and updates for regularization of activities and Pharlab’s market commercialization. **Requirements and qualifications** **Education** ---------------- * Completed bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or related fields. **Experience** ------------ * Experience in Regulatory Affairs. **Knowledge** ----------------- * Anvisa regulations and inspections; * Regulations for Product Registration and Post-Registration; * Good Manufacturing Practices (GMP); * Product registration approval; * Intermediate Office Suite skills; **Additional information** **Work model and location** ------------------------------ * On-site – Lagoa da Prata/MG. **Working hours** ----------------------- * Administrative – Monday to Thursday from 07:00 to 17:30 * Friday from 07:00 to 16:30. **Benefits** -------------- * Meal allowance: BRL 600.00/month; * Life insurance; * Medicines from production line: 100% discount (employee, spouse, and children up to 14 years old, with medical prescription); * Conexa Saúde: telemedicine, telepsychology, and telenutrition; * GoGood: fitness activity plans; * Birthday day off; * Childcare allowance. Pharlab Pharmaceutical Industry | Founded in 2000 ***A Minas Gerais-based pharmaceutical company active in the generics, similars, and over-the-counter segments for over 20 years.*** Are you looking for a **career opportunity** to grow professionally and wish to join your efforts with us? Then come and make health with us! We are a company in constant evolution, which values talent, creativity, and diversity among our employees. At Pharlab, we develop our teams to always go beyond, through a dynamic, challenging environment that promotes skill development. We leverage the **experience of a French multinational**, enabling our growth according to international standards. Moreover, we are part of Servier's generics division alongside Biogaran (France) and Egis (Hungary). Learn more by clicking here. Explore our opportunities! ### **WHAT IS THE CORE OF OUR BUSINESS?** Our focus areas for investment are: * **R&D:** research and development of molecules * **CAD**: storage and distribution center * Organizational Human Development We serve the following channels: * **Retail Chains Channel:** direct service through representatives supported by the Trade Marketing team. * **Hospital Channel:** operation through distributors and representatives in public institutions. * **Pharmacy Channel:** direct team operating through partner distributors focusing on independent pharmacies across multiple states. ### **WHY ARE WE HERE?** We are here to combine efforts in every link where we operate. **Because we believe that TOGETHER we are healthcare!** Our commitment is based on: * **Grow by sharing:** We take joy in being part of Pharlab. We are always available to customers, and our team spirit drives us to continuously improve the company. * **Commit to succeed:** With confidence, determination, and respect, we are all committed to the success of Pharlab and all our customers. * **Care:** We are professional and impartial in carrying out our activities and relationships with customers. We use communication to align expectations and maintain transparency in relationships. * **Dare to innovate:** We are creative and optimistic, acting quickly to improve processes and solutions for customers.

R. Joaquim Gomes Pereira, 854 - Lagoa da Prata, MG, 35590-000, Brazil

R$600/biweek

Production Process Leader64539049580545122

Indeed

Production Process Leader

Description: Education: Minimum: Completed high school. Experience: In related activities. Desirable: 1 year in the pharmaceutical industry. Knowledge:* Good Manufacturing Practices (GMP); * Semi-solid production and compression processes; * Leadership; * Basic computer skills. * Be responsible for the quality, reliability, and performance of resources, services, and information generated by tasks, meet deadlines for internal demands and legal obligations under their responsibility; * Obtain information from the previous shift worker and/or immediate superior regarding service progress and production schedule for their shift, in order to start their work period, as well as pass this same type of information on to the next shift worker; * Ensure production lines are supplied according to the received schedule; * Be responsible for feeding machines with previously selected raw materials to maintain a production pace according to the received schedule; * Separate materials for reuse, avoiding waste; * Monitor team performance, providing guidance when necessary, aiming to maintain work pace, quality, and productivity. * Provide instructions for operating equipment used in the compression process and other area equipment, keeping them in perfect working condition; * Instruct the work team in their area about company regulations, work procedures, safety procedures, and other job-related aspects. * Identify causes of equipment malfunction and arrange necessary repairs as quickly as possible. * Fill out documents to maintain a production record for management monitoring and provide material for analysis and decision-making; complete the Production Order document. * Organize the work area, maintaining cleanliness and organization according to internal procedures and regulatory agencies; * Perform activities according to established operational technical standards, following Pharlab norms and aspects of quality, Good Manufacturing Practices (GMP), workplace safety, environmental preservation, and sustainability, as well as use * PPEs and uniforms, contributing to eliminating situations that could pose risks of accidents, environmental degradation, and product quality issues; * Maintain hygiene, organization, and cleanliness conditions at their workstation, administrative or operational, performing cleaning of machines, equipment, tools, desks, and/or work materials used, as well as storing them in appropriate locations and manner, in compliance with standards set by the National Health Surveillance Agency - ANVISA; * Support the immediate supervisor in matters related to their area of activity, presenting and discussing problems and irregularities, in order to assist in defining procedures and actions to be adopted. 2511190202461784190

R. Joaquim Gomes Pereira, 854 - Lagoa da Prata, MG, 35590-000, Brazil

Negotiable Salary