Sr. Regulatory Affairs Officer
FMCG (Fast Moving Consumer Goods) Industry
đ 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 brandâs 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.
đ Why Join Us:
Impactful Role in Innovation:Â Bring groundbreaking products to market by ensuring compliance, directly influencing DEGâs product portfolio and reputation.
High Compliance Standards:Â Lead the charge in setting industry standards for regulatory excellence, working to support safe, trusted products.
Collaborative Growth Environment:Â DEG values development and teamwork, offering you leadership in regulatory strategy and cross-functional collaboration.
đ What We Expect:
1. Form and Maintain Collaborative Relationships with External Partners â Youâll play a key role in establishing and nurturing productive relationships with external partners, supporting efficient communication and proactive compliance. Within a set period, youâll be expected to develop strategic connections that facilitate smooth collaboration and timely responsiveness to regulatory requirements.
2. Maintain a High Regulatory Compliance Rate â In this role, youâll drive the compliance of all regulatory submissions, from product approvals to timely renewals, ensuring DEGâs 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 â As the guardian of DEGâs regulatory documentation, youâll ensure that all records are meticulously accurate and audit-ready at all times.
đ You Should Have:
Bachelorâs 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. Masterâs degree or relevant certifications are 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
đ 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