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    Regulatory Affairs Officer - Philippines, Quezon City, Pilipinas - Dragon Edge Group

    Dragon Edge Group
    Dragon Edge Group Philippines, Quezon City, Pilipinas

    6 araw ang nakalipas

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    Buong oras
    Paglalarawan

    REGULATORY AFFAIRS OFFICER

    FMCG (Fast Moving Consumer Goods) Industry

    Introduction: If you're eager to be part of a team shaping the future of product development, welcome to Dragon Edge Group – where pioneering spirit aligns seamlessly with regulatory expertise. We're actively seeking a skilled Regulatory Affairs Officer to join our dynamic team. As an integral part of the tribe, you'll ensure adherence to regulatory standards, guiding our innovative products through approval processes. Join us in advancing Dragon Edge Group's 17-year legacy and contributing to our ambitious goal of delivering 100 million DEG products by 2031.

    Why Join Us:

    · Innovative Regulatory Challenges: As a Regulatory Affairs Officer, you'll work on cutting-edge products, ensuring they meet and exceed industry standards while contributing to the company's legacy of innovation.

    · Commitment to Ethical Practices: Be a part of a company that prioritizes ethical business practices. At Dragon Edge Group, integrity is at the core of what we do.

    · Continuous Learning Opportunities: Stay on top of the latest regulatory trends and advancements, further enhancing your expertise in a rapidly evolving field.

    What We Expect:

    1. Regulatory Compliance Metrics – ensure compliance with local and international regulations. Serve as the primary contact with the FDA; review, analyze, and respond to FDA communications and meetings by the regulatory deadline. Track and report on the number of successful regulatory approvals, audits, and compliance adherence to industry standards. Your role is pivotal in safeguarding the company's reputation and ensuring products meet all necessary legal requirements.

    2. Change Control Effectiveness - assess the effectiveness of change control processes in managing modifications to existing products or processes while maintaining regulatory compliance. Monitor the number and impact of changes, evaluating how well the company adapts to regulatory updates and product modifications.

    3. Regulatory Risk Management – assess and report on the identification and mitigation of regulatory risks. Your role involves anticipating potential regulatory challenges by keeping up to date with changes in regulatory legislations that may impact the company and perform gap analysis as necessary.

    4. Regulatory Submission Timeliness – track and optimize the timeliness of regulatory submissions for product registrations, licenses, and certifications. Your efficiency in navigating submission processes directly impacts the speed at which products can enter the market, contributing to overall business agility.

    5. Cross Functional Collaboration - maintain clear and efficient communication channels between your department and other departments. Measure the effectiveness of information flow, ensuring that regulatory updates, requirements, and changes are communicated promptly and comprehensively across the team.

    You Should Have:

    · Educational Background: Bachelor's degree in Allied Health Courses

    · Licensed Professional: Must be a licensed professional from any allied health course.

    · Regulatory Affairs Experience: Minimum of 1-year regulatory affairs experience in Cosmetics, Household, Medical Device, Food or Drugs

    · Regulatory Knowledge: With subject matter expertise on all regulatory matters related to assigned regulatory projects. Can provide regulatory guidance and inputs to departments or development project teams regarding design and development, change control, testing, labeling, and marketing of products.

    Key Behavioral Competencies:

    · Critical Thinking

    · Excellent Writing, Oral, & Organizational Skills

    · Initiative

    · Relationship Building

    · Attention to Detail

    · Problem Solving

    · Resilience

    · Time Management

    · Passion for Learning


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