Sr. Regulatory Affairs Officer

Introduction: Welcome to Dragon Edge Group, where visionary products become household names globally. We're on the lookout for an experienced and meticulous Sr. Regulatory Affairs Officer to lead our regulatory strategy and ensure seamless market access for our innovative products.

As the steward of our compliance and regulatory integrity, your expertise will safeguard our brand's reputation, facilitating the successful launch and expansion of groundbreaking products across diverse markets. Your role is crucial to our ambitious vision of delivering 100 million DEG products by 2031, reinforcing our 17-year legacy of excellence. Join us in building global brands that inspire trust, safety, and innovation, starting right here in the Philippines.

Why Join Us:

• Impactful Role in Innovation: Bring groundbreaking products to market by ensuring compliance, directly influencing DEG's product portfolio and reputation.
• High Compliance Standards: Lead the charge in setting industry standards for regulatory excellence, working to support safe, trusted products.
• Collaborative Growth Environment: DEG values development and teamwork, offering you leadership in regulatory strategy and cross-functional collaboration.

What We Expect:

1. Form and Maintain Collaborative Relationships with External Partners You'll play a key role in establishing and nurturing productive relationships with external partners, supporting efficient communication and proactive compliance. Within a set period, you'll be expected to develop strategic connections that facilitate smooth collaboration and timely responsiveness to regulatory requirements.

2. Maintain a High Regulatory Compliance Rate In this role, you'll drive the compliance of all regulatory submissions, from product approvals to timely renewals, ensuring DEG's product lines meet FDA standards without delay. Your responsibility includes achieving and sustaining a high regulatory compliance rate, critical for uninterrupted market access and consistent brand integrity.

3. Maintain High Audit Readiness and Documentation Accuracy As the guardian of DEG's regulatory documentation, you'll ensure that all records are meticulously accurate and audit-ready at all times.

You Should Have:

• Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field; advanced degree or Regulatory Affairs Certification (RAC) is preferred
• Licensed Professional from any allied health courses. Master's degree or relevant certifications is a plus
• With 3-5 years experience in regulatory affairs
• Skilled in building and maintaining professional relationships with regulatory bodies, especially the FDA
• Familiarity with regulatory submission tools and tracking systems.
• Proven track record of successful regulatory submissions, approvals, and compliance management.
• Proficient in regulatory affairs software and document management systems

Key Behavioral Competencies:

• Regulatory Knowledge & FDA Expertise
• Communication and negotiation strategy
• Accuracy and thoroughness in all tasks
• Judgement/Decision Making
• Process optimization
• Develops and maintains positive relationships
• Organization/Planning