35 Latam Jobs - Page 2

Required Skills: Strong understanding of international pharmaceutical markets and regulatory landscapes. Proven experience in generating business leads and closing export deals.. Ability to travel internationally as required.

Role & responsibilities: Compilation and review of registration dossiers as per Country specific guidelines and requirements. Specific experience required for Latam American market including Brazil, Mexico. Should have to work for EU market and hands on experience about the submission Management system. Review of all Technical Documents (DMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.) Compilation of deficiency responses of new product submission and Backlog dossier To review the proposal for any post-approval changes as per the current regulatory guidance. To prepare and submit the variation for post approval changes. To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation. To review various artworks & comments for ongoing commercial supply & products for the new launch. To prepare and maintain various registration Data base & updating at Central Depository. Preferred candidate profile: Candidate must have core International Regulatory Affairs experience in Latam and EU market can only apply. Candidate should have good technical job knowledge of EU and other regulatory. Should have good communication and interpersonal skills

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.

Prepare, submit regulatory dossiers for new product registrations Coordinate and manage the submission of regulatory documents Facilitate communication with health authorities, responding to queries Required Candidate profile M. Pharm (Female Candidate Preferred) 1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired. Excellent communication skills.

Job Title: Senior Manager (International Business Development) Location : Worli, Mumbai EDUCATION : MBA in Marketing or International Business EXPERIENCE: 10-15 Years in International Business Reporting to: President-International Business Key Role: Development of new business and managing existing business in LATAM and CIS. NEW BUSINESS DEVELOPMENTS Identification of new markets based on ease of entry and regulatory framework and market potential. Identify new products for the market based on export data analysis and market surveys. Identification of local partners for business, based on their financial strength, local govt contacts and distribution set up. Market survey to identify right products at right prices. Facilitating agreement between the company and the new customers. Follow-up for registration of products in the new markets. Securing business from the new markets after registration and follow up for payments. MANAGING EXISTING BUSINESS Timely procurement of orders from the existing customers. Follow-up for advance payments/ LC before production. Follow-up for production with PPIC. Follow-up for any post shipment payment. PERFORMANCE AND TREND ANALYSIS Trend analysis of new and existing markets. Act as country guardian for the assigned market. Liaison with country managers for orders, secondary sales and payments. Liaison with regulatory team for new product registration in the assigned markets. Maintain record of sales and collections of the assigned markets. If the above job profile interests you, plz revert back with your updated profile to rajbm@mlopssol.com for further proceedings.

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representatives, which located out station. Must have excellent communication skills Must have excellent in analyzing skills Excellent in accuracy and focus Self-motivated and enthusiastic Perks and Benefits: Health Insurance Shuttle facility, Fix office timing, Career growth training & development

Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies.

Overview The SAP S4 Migration is a comprehensive, multi-year program spanning over four years, aimed at modernizing the current SAP PIRT landscape. This initiative covers various regions including MENA, LATAM, PGCS, APAC, and Europe. The goal of this program is to prepare the SAP system for the future, aligning it with PepsiCo's digital transformation journey. The project involves planning, executing, and overseeing the successful migration of data and business processes from existing SAP ECC systems to S/4HANA. This will include designing remediation of deprecated functionalities, design new functionalities for obsolete functionalities, executing data migration objects, and ensuring data quality and integrity throughout the process. This will also be working in close collaboration with technical and business stakeholders to align goals and expectations. The project aims to replace legacy systems by implementing the SAP S/4 HANA business suite. This suite will cover various functions including Record to Report (RTR), Financial Planning & Analysis (FP&A), Order to Cash (OTC), Purchase to Pay (PTP), Make to Deploy (MTD), Enterprise Asset Management (EAM), Warehouse Management (WM) and Trade Promotional Management (TPM). Responsibilities Ensure Seamless Migration: Ensure that SAP ECC processes are remediated and migrated to SAP S/4 RTR out any design gaps focussing on GL and Assets and other areas required Design and Build: Create design documentation where existing functionalities have become obsolete. Remediate object which are identified by for remediation System Readiness: Prepare the current SAP system for migration by applying necessary updates and configurations, such as SAP notes and pre-migration checks. Data Migration: Oversee the technical migration of data from legacy systems to the SAP S/4HANA environment. Ensure data quality, integrity, and compliance throughout the migration process by conducting data validation and reconciliation Data Validation: ensuring data integrity and minimal disruption to business operations. Comprehensive Testing: Conduct thorough testing to validate the functionality and performance of the new system, ensuring it meets all business requirements and standards. Change Management: Support the Change management in identifies processes and/or transactions which will get impacted. Training and Support: Provide training and support to super users for the changes to ensure a smooth transition and effective use of the new system. Issue Resolution: Identify and resolve data migration issues promptly, collaborating with data migration and tech team as needed. Track issues throughout the migration life cycle and ensure issue resolution in timely manner for the overall project success Promote Collaboration: Foster an environment where communication, teamwork, and innovation are encouraged. Governance and Compliance: Ensure adherence to the internal IT operating model, including technology standards, project life cycle methodology, release management, change management, and other related processes and procedures, SLAs, and controls compliance. Accountable for ensuring proper governance is followed for all RTR areas Project Communication: Own project status and communication for all related work in the project. Accountable for ensuring project status reporting is done weekly and senior executive-level communications are timely and accurate. Reuse Asset: Create reuse asset which can be leveraged during migration to optimize the efforts for sectors planned later in the migration journey. Qualifications Minimum Bachelors degree is required. Computer Science or Information Systems is preferred. 10+ years of experience configuring, deploying and managing SAP ERP with a focus on SAP RTR GL, Fixed Assets, Credit Management, AP and AR. Experienced in 2-3 Implementation Project in SAP S4 for RTR Process knowledge and SAP solution mapping experience for GL external reporting, Interfaces to applications like Blackline, Celonis. Experience in SAP Profitability Analysis and Product Costing Integration across other functional areas, i.e., Procure to pay, Make to Deploy & Order to Cash Prior experience on S4 Migration or experience data validation strategy would be preferred. Deep understanding of project test phases and testing automation tools. Fully aware of the SAP security design implications through global roles. Familiar to the GRC best practices in large corporations as PepsiCo Dispatches standard SAP quality issues with OSS (Online SAP Services) and follows up the required break fixes Demonstrated Leadership skills, including planning, organization, prioritization, collaboration Demonstrated ability to effectively communicate with all levels of the organization Ability to work flexible hours based on varying business requirements Knowledge and experience in the following tools, disciplines and processes are nice to have: SAP SolMan 7+, Azure DevOps, Quality Center and MS Project Solves complex problems within their work team Strong influencing, facilitating, and consulting skills in working with stakeholders at all levels in the organization and across departments Ability to quickly adapt to changes in timelines and sequences Ability to work collaboratively across project teams. Possess strong analytical skills Adaptability and flexibility including ability to manage deadline pressure, ambiguity and change Ability to clear obstacles for teams to deliver Experience with LATAM, Europe, MENA and APAC preferred

Quantum World Technologies Inc. is hiring for LATAM/Mexico IT Recruiter role, if interested drop your cv at deeksha@quantumworldit.com Info@quantumworldit.com Shift: (6:30 PM to 3:30 AM) Experience: Freshers and Experienced candidates can apply Location: Lucknow