Regulatory Affairs Officer Resume
Summary : As a Regulatory Affairs Officer, experienced in ensuring regulatory compliance for industry/sector, tracked record of successfully navigating complex regulatory landscapes and developing strategies to support compliance and business objectives.
Skills : Regulatory Knowledge, Risk assessment.
Description :
- Responsible for leading regulatory compliance efforts for specific products/areas by relevant regulatory bodies.
- Responsible for developing and implementing regulatory strategies to support product approvals and market access.
- Responsible for conducting regulatory assessments and gap analyses to identify areas for improvement and risk mitigation.
- Responsible for preparing and submitting regulatory filings, including list-specific types of submissions, such as pre-market notifications, and product registrations.
- Responsible for collaborating cross-functionally with R&D, quality assurance, marketing, and legal teams to ensure regulatory compliance throughout the product lifecycle.
- Responsible for staying updated with industry regulations and trends to advise on regulatory strategy and potential impacts on business operations.
- Responsible for spearheading the successful approval of several new products by collaborating closely with cross-functional teams to ensure the timely submission of accurate applications.
Experience
10+ Years
Level
Senior
Education
Bachelor's Degree in Life Sciences
Regulatory Affairs Officer Resume
Summary : As a Regulatory Affairs Officer, responsible for assisting in preparing regulatory submissions and documentation for product approvals, responsible for conducting regulatory research and analysis to support compliance efforts.
Skills : Risk mitigation strategies, Analytical.
Description :
- Developed and implemented regulatory strategies to support product approvals, market access, and compliance objectives.
- Assessed regulatory risks and opportunities.
- Collaborated with internal teams such as research and development (R&D), quality assurance, legal, marketing, and external stakeholders to ensure regulatory compliance throughout the product lifecycle.
- Conducted research and analysis on regulatory requirements, trends, and best practices to inform regulatory strategy, decision-making, and compliance activities.
- Interacted with regulatory agencies to address inquiries, submissions, and compliance matters.
- Prepared responses to agency inquiries and participated in regulatory inspections and audits.
- Worked independently and collaboratively in a team environment, passionate about learning, and committed to continual improvement.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree in Life Sciences
Regulatory Affairs Officer Resume
Headline : As a Regulatory Affairs Officer, responsible for coordinating internal and external audits to ensure adherence to regulatory requirements, and responsible for contributing to regulatory training programs for employees to enhance their understanding of compliance standards.
Skills : Problem-solving abilities, Communication.
Description :
- Identified regulatory challenges and finding practical solutions to address them while maintaining compliance and business objectives.
- Analyzed regulatory data, trends, and changes to assess their impact on business operations and regulatory compliance.
- Managed regulatory documentation, databases, and records to ensure completeness, accuracy, and accessibility for audits and compliance purposes.
- Ensured that products, processes, and operations comply with relevant laws, regulations, and standards in the industry.
- Involved in staying updated with regulatory changes and developments.
- Prepared and submitted regulatory documents and filings required by regulatory agencies.
- Learned quickly and adapted to new situations.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Life Sciences
Regulatory Affairs Officer Resume
Objective : As a Regulatory Affairs Officer, responsible for maintaining regulatory databases and documentation to support audit readiness. Understood and ensured compliance with relevant laws, regulations, and standards in the industry.
Skills : Project Management, Collaboration.
Description :
- Prepared and submitted regulatory documents, such as pre-market notifications, product registrations, and other submissions required by regulatory agencies.
- Assessed regulatory risks and develop strategies to mitigate them, ensuring business continuity and compliance.
- Worked effectively with teams across departments like R&D, quality assurance, legal, and marketing to ensure regulatory compliance throughout the product lifecycle.
- Developed and implemented strategies to support product approvals, market access, and overall regulatory compliance goals.
- Stayed updated with industry regulations, trends, and best practices to inform regulatory strategy and decision-making.
- Effectively communicated regulatory requirements and implications to internal teams, external stakeholders, and regulatory agencies.
- Maintained accuracy and precision in regulatory documentation, submissions, and compliance activities.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree in Life Sciences
Regulatory Affairs Officer Resume
Summary : As a Regulatory Affairs Officer, maintained regulatory files, tracking regulatory submissions, and preparing regulatory reports, developed and delivered regulatory training programs to educate employees on compliance standards, policies, procedures, and changes in regulatory requirements.
Skills : Adaptability, Risk Management.
Description :
- Assessed regulatory risks associated with products, processes, and operations, and developed strategies to mitigate risks while maintaining compliance and business objectives.
- Monitored regulatory compliance activities, conducted internal audits and assessments, and implemented corrective and preventive actions as needed to address compliance issues.
- Prepared and submitted regulatory reports, notifications, and updates to regulatory agencies as required by regulations and guidelines.
- Kept abreast of industry trends, regulatory developments, and best practices in regulatory affairs to ensure proactive compliance and strategic planning.
- Assisted with the administration and monitoring of RJF’s New Products Review Process.
- Worked with business unit leaders to develop, communicate, and implement strategies, procedures, and technology systems designed to enhance the firm’s compliance function.
- Ensured procedures are appropriately documented and referenced in the firm’s compliance manuals and standard operating procedures.
Experience
10+ Years
Level
Senior
Education
Bachelor's Degree in Pharmacy
Regulatory Affairs Officer Resume
Headline : As a Regulatory Affairs Officer, prepared and reviews CMC documentation required to support submissions IMPD updates, MAA, post approval variations and renewals, evaluated of proposed changes and participate in deciding if variation applications are required for MAs.
Skills : Attention to Detail, Problem-Solving.
Description :
- Ensured dossier and file history is kept updated and secure archiving of correspondence and documentation relevant for the MAs.
- Closed collaboration with headquarter and 3rd party manufacturers for planning of renewals / variations.
- Secured that MAs are withdrawn if requested by relevant stakeholder.
- Participated in the on-going development of the department.
- Participated and delivered regulatory input in regulatory/cross functional projects.
- Handled medical inquiry request from customer phone.
- Prepared and ensured timely submission of national texts and mock-ups for Global products (MRP/DPC and CP) in the Nordics within own Therapeutic Areas.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
Regulatory Affairs Officer Resume
Headline : As a Regulatory Affairs Officer, participated in the implementation of the new structure with e-2-e ownership in the RA LCM Global Product team. Responsible for evaluating and preparing product registration dossiers for submission to the Philippine Food and Drug Administration and health authorities in different countries like Singapore, Hong Kong, Myanmar, Dubai, Ghana, and others.
Skills : Regulatory Research, Communication and Interpersonal Skills.
Description :
- Responsible for reviewing food and drug product information to be reflected in the patient information leaflet, package inserts, and other labeling materials.
- Responsible for liaising to represent the company by visiting the regulatory authority to conduct follow-ups and queries regarding product applications.
- Responsible for providing reliable and accurate information and coordinated with Medical Affairs, Research & Development, Quality Control, Quality Assurance, Warehouse, Business Development Group, and other departments in the organization when consulted regarding regulatory requirements, policy, and guidelines.
- Responsible for attending and assisting the department head in conducting research and collecting written updates relating to FDA updates.
- Responsible for regularly updating our immediate superior and division head on the accomplishments done and pending tasks through monthly operations reports.
- Responsible for responding to regulatory agencies regarding product information or issues.
- Responsible for prioritizing project-related tasks to efficiently complete essential tasks.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
Regulatory Affairs Officer Resume
Headline : As a Regulatory Affairs Officer, responsible for increasing efficiency in reporting adverse events by streamlining data collection methods and improving interdepartmental collaboration, responsible for leading efforts to obtain necessary certifications for products, allowing for increased market access and revenue growth.
Skills : Cross-Functional Collaboration, Regulatory Strategy Development.
Description :
- Responsible for developing comprehensive employee training programs focusing on critical aspects of industry regulations, resulting in increased awareness among staff and a strengthened compliance culture.
- Responsible for contributing to positive audit outcomes by maintaining comprehensive knowledge of current regulations and proactively updating relevant policies and procedures accordingly.
- Responsible for coordinating multidisciplinary review teams to evaluate product safety concerns, resulting in more informed decision-making and risk mitigation efforts.
- Responsible for driving continuous improvement in regulatory processes by identifying areas of inefficiency, proposing solutions, and implementing changes that led to measurable improvements in overall performance.
- Responsible for reducing response time to regulatory inquiries by establishing a robust tracking system for all incoming communications.
- Responsible for managing fees and applications, tracked product progress, and handled all responses to regulatory inquiries.
- Responsible for devising and deploying techniques for obtaining the earliest possible approval for each product.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
Regulatory Affairs Officer Resume
Headline : As a Regulatory Affairs Officer, responsible for performing and documenting quality control checks to maintain compliance with company initiatives, and responsible for enhancing company compliance with FDA regulations through thorough review and editing of product labeling and promotional materials.
Skills : Regulatory Filings, Risk Assessment.
Description :
- Responsible for directing documentation efforts to comply with domestic and international regulations and standards.
- Responsible for supporting global market expansion efforts through research, analysis, and interpretation of international regulatory requirements.
- Responsible for facilitating smooth communication between departments by serving as the primary liaison between regulatory affairs and other functional areas within the organization.
- Responsible for consulting with regulatory representatives to manage filings, applications, and reports.
- Responsible for providing valuable input on product development initiatives, and offering expert guidance on potential regulatory challenges or concerns throughout the process.
- Responsible for cultivating strong relationships with key regulators, fostering open lines of communication that expedited issue resolution and facilitated a more collaborative approach to compliance matters.
- Responsible for working with governance committees to make and evaluate plans.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
Regulatory Affairs Officer Resume
Headline : As a Regulatory Affairs Officer, responsible for assisting in the preparation and execution of successful pre-approval inspections by providing necessary documentation, training staff members, and addressing any issues promptly, responsible for championing the adoption of new regulatory strategies by staying abreast of industry trends, attending relevant conferences, and participating in networking events with key stakeholders.
Skills : Regulatory Compliance, Marketing SKills.
Description :
- Responsible for streamlining regulatory submission processes by developing and implementing efficient documentation procedures.
- Responsible for preparing and maintaining document inventory for core dossier preparation.
- Responsible for working with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Responsible for recommending improvements to processes.
- Responsible for improving efficiency in document management systems, allowing for easier access to information during inspections or audits.
- Responsible for minimizing the risk of non-compliance penalties by conducting regular internal audits and implementing corrective actions as needed.
- Responsible for ensuring high-quality submissions for various product categories through meticulous attention to detail in preparing documents according to agency guidelines.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
