Job Summary: 

• Serve as the subject matter expert on regulatory affairs between manufacturers and internal and external stakeholders in the North Latam region.
• Communicate on time and accurately on specific regulatory requirements and advise business partners/product design teams of regulatory strategy and requirements.
• Prepare regulatory submissions for new products/solutions, product changes, and re-registrations, according to plan.
• Plan and maintain registration information and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
• Provide support to currently marketed products, including input on change requests or any other requests part of the life cycle management.
• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
• Support development of regulatory plans, risk assessments and required activities to meet regulatory requirements and product registrations to maintain compliance.
• Act as an advisor cross-functionally to meet the schedules and/or solve technical questions.

Skills on Resume:

• Regulatory Expertise (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Submission Management (Hard Skills)
• License Compliance (Hard Skills)
• Product Support (Hard Skills)
• Record Maintenance (Hard Skills)
• Risk Planning (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary: 

• Review of formulation (ingredients, nutrient levels) and other technical data associated with new product formulations to ensure in line with current legislation.
• Provide advice on the suitability of formulations for the Israeli market.
• Represent Regulatory Affairs in cross-functional New Process Introduction Teams.
• Develop new (and maintain existing) product labels and datasheets in line with current legislation.
• Liaise with manufacturing sites, corporate head-office and affiliate departments on regulatory issues.
• Liaise with external regulatory authorities.
• Review new legislation and identify implications for Abbott Nutrition products.
• Provide technical support to the Commercial Division.
• Ensure compliance with statutory obligations in respect of the above.

Skills on Resume:

• Formulation Review (Hard Skills)
• Regulatory Advisory (Hard Skills)
• Label Development (Hard Skills)
• Authority Liaison (Soft Skills)
• Legislation Analysis (Hard Skills)
• Technical Support (Hard Skills)
• Compliance Assurance (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary: 

• Prepare regulatory submissions for the US, EU and other key international markets and ensure timely execution to support product launches.
• Prepare and perform document Legalization for International product registrations/tenders.
• Clearly communicates information regarding regulatory submissions, new or changing regulatory requirements, and projects to appropriate internal and external contacts.
• Participate in product Recalls, vigilance decisions and global response to product compliance issues.
• Participate in internal and external audits.
• Ensure products are shipped to regions where Regulatory approvals have been obtained and resolve any import/ship holds in a timely manner.
• Research and apply appropriate regulatory responses to support the business needs and projects.
• Evaluate applicable laws and regulations to determine impacts on company activities.
• Exercise independent judgment in the monitoring of and compliance with current global regulations and standards.
• Partner with departments to develop appropriate feedback loops and process improvements to drive product compliance.

Skills on Resume:

• Regulatory Submissions (Hard Skills)
• Document Legalization (Hard Skills)
• Regulatory Communication (Soft Skills)
• Compliance Management (Hard Skills)
• Audit Participation (Hard Skills)
• Import Resolution (Hard Skills)
• Regulation Analysis (Hard Skills)
• Process Improvement (Soft Skills)

Job Summary: 

• Familiarize with standard concepts, practices, and procedures within a particular field.
• Develop and contribute to the content and format for regulatory submissions and related supplements and amendments.
• Understand FDA processes, guidelines, and requirements.
• Rely on experience and judgment to plan and accomplish goals.
• Review and monitor complaint and adverse event reports.
• Perform a variety of tasks as identified by management.
• Work with cross-functional groups to collect information necessary for regulatory filings.
• Interact with all levels of site management (Vice Presidents to supervisory levels).
• Work under general supervision.
• Work both independently and within a team in a fast-paced environment to achieve business objectives.
• Recognize issues that should be brought to management.

Skills on Resume:

• Regulatory Knowledge (Hard Skills)
• Submission Development (Hard Skills)
• FDA Understanding (Hard Skills)
• Goal Planning (Soft Skills)
• Report Monitoring (Hard Skills)
• Information Gathering (Soft Skills)
• Team Collaboration (Soft Skills)
• Issue Escalation (Soft Skills)

Job Summary: 

• Collaborate with project team members, define project requirements and timelines.
• Organize, create, and maintain project plans.
• Communicate project status to the cross-functional team and regulatory management.
• Interface with project team members to drive regulatory and corporate initiatives to completion.
• Provide regulatory reports (monthly, quarterly, etc.) to regulatory management and other departments.
• Review and approve product labelling and marketing material.
• Initiate new package inserts and other required product labelling.
• Establish and maintain the Global labelling database.
• Collaborate with Global Packaging/Labelling Operations to ensure that the final product meets package labelling requirements for intended destinations.
• Prepare regulatory submissions and filings.
• Maintain regulatory files and documents.
• Keep abreast of regulatory requirements, which include monitoring EMEA and other agencies' regulations and standards.
• Assist with health hazard evaluations, adverse event reporting, product recalls/withdrawals, and data entry into Clinicaltrials.gov.
• Responsible for regulatory project management.
• Author and develop guidance for regulatory positioning/strategies (align with senior management) and communicate to the regional.

Skills on Resume:

• Project Coordination (Soft Skills)
• Regulatory Planning (Hard Skills)
• Status Communication (Soft Skills)
• Initiative Execution (Soft Skills)
• Label Review (Hard Skills)
• Database Management (Hard Skills)
• Regulation Monitoring (Hard Skills)
• Risk Management (Hard Skills)

Job Summary: 

• Coordinate all activities relating to regulatory compliance and the submission of specified documentation.
• Establish and maintain a positive and effective relationship with various regulatory bodies.
• Work with the Product and Development teams on regulatory requirements, documentation and testing needed for various submissions.
• Reviewing product requirements, regulatory submissions, updates and the resolution of issues and questions from regulatory agencies.
• Collaborate with Product and Development teams to upskill, train and update them on regulatory obligations and changes.
• Communicate status updates, regulations, and standards to key stakeholders.
• Highlight the issues and risks associated with regulatory strategies/plans and offer solutions.
• Assist with the development of a regulatory framework for products that improve the care for patients with cancer.

Skills on Resume:

• Regulatory Coordination (Hard Skills)
• Authority Relations (Soft Skills)
• Submission Management (Hard Skills)
• Issue Resolution (Soft Skills)
• Team Training (Soft Skills)
• Stakeholder Communication (Soft Skills)
• Risk Mitigation (Hard Skills)
• Framework Development (Hard Skills)

Job Summary: 

• Coordinate, prepare and submit registration applications to the UK and/or Irish regulatory authorities to high standards.
• Support the launch of new products and the life cycle management of the existing product portfolio.
• Assist in strategic input into the development of registration activities for the commercialisation of products.
• Support preparation, distribution and follow-up of registration documentation required in the EU (UK and Ireland in particular).
• Work cross-functionally with Global Business Units and Global functions to ensure project needs are met compliantly.
• Input into the review of promotional and non-promotional materials from a regulatory perspective.
• Ensure data supplied to authorities is of a high standard and in a timely manner.
• Provide regulatory input to the commercial strategic and operating planning process.
• Deputise for the manager/senior managers.

Skills on Resume:

• Registration Management (Hard Skills)
• Product Launch (Hard Skills)
• Strategy Planning (Soft Skills)
• Document Support (Hard Skills)
• Team Collaboration (Soft Skills)
• Material Review (Hard Skills)
• Data Compliance (Hard Skills)
• Regulatory Leadership (Soft Skills)

Job Summary: 

• Prepare and submit regulatory submissions with support from regulatory operations.
• Provide strategic input by participation in internal (e.g., CVTs, LLCM) working groups to meet company objectives.
• Maintain the product label and packaging in line with currently registered authorization details according to the relevant local and EU legislation.
• Contribute to compliance with all regulatory requirements (e.g., timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOPs and supporting systems).
• Maintain an awareness of regulatory guidelines/directives/national requirements in order to provide appropriate advice.
• Contribute to positive relationships with the local health authorities, in general, and on product-specific topics.
• Support and contribute to GRA-EMEA initiatives.
• Contribute to initiatives around lessons learned and change management to ensure efficiency gains.
• Accountable for artwork activities.
• Responsible for close contact and working with all internal stakeholders.

Skills on Resume:

• Regulatory Submissions (Hard Skills)
• Strategic Input (Soft Skills)
• Label Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Guideline Awareness (Hard Skills)
• Authority Relations (Soft Skills)
• Change Management (Soft Skills)
• Artwork Coordination (Hard Skills)

Job Summary: 

• Complete product regulatory assessments and approval to comply with EMEA regulatory and company requirements.
• Serve as a team contact to gather and submit product regulatory information into the company systems (Veeva).
• Review new and existing EMEA regulatory guidance documents and prepare comments on new documents.
• Participate in Project Teams for new product development.
• Responsible for driving key initiatives to maintain regulatory data, create new tools and mechanisms for maintaining regulatory data over time.
• Provide regulatory support in process improvements that drive efficient regulatory processes.
• Keep abreast of new or revised regulations regarding IVD Medical Devices, with emphasis on the impending EU IVD Regulation.
• Support training and/or communicate appropriate material to internal staff to aid in compliance.

Skills on Resume:

• Regulatory Assessment (Hard Skills)
• Data Submission (Hard Skills)
• Guideline Review (Hard Skills)
• Project Participation (Soft Skills)
• Data Management (Hard Skills)
• Process Improvement (Soft Skills)
• Regulation Monitoring (Hard Skills)
• Compliance Training (Soft Skills)