Job Description Pave the Way in Health & Wellness Logistics Excellence Are you a visionary in the field of Regulatory Affairs, seeking to leave an indelible mark on the global landscape of Health, Wellness & Fitness Do you crave a role that offers not just professional elevation, but the chance to shape industry standards and carve out your legacy Look no further! Our client, a leading international company at the forefront of revolutionizing health and wellness solutions, are on the hunt for an exceptional CMC Regulatory Specialist to join their dynamic team. This is not just a job it's a rare opportunity for you to propel your career to new heights, all while making a lasting impact without having to leave the comfort of your home country. As a CMC Regulatory Specialist, you will be responsible for preparing global product CMC submissions (ANDA and market application) for pharmaceutical products (OTC) using templates for eCTD publishing. Additionally, you will provide regulatory guidance to ensure compliance with 21 CFR Part 314, Applications for FDA Approval to Market a New Drug and Abbreviated New Drug.
Employment Type: Full-time
Shift: Night Shift Mon - Fri 09:00 PM - 06:00 AM
Work Setup: Hybrid, Ortigas/Makati/Quezon City (Will work remotely majority of the time)
Qualify to Thrive: B.S. in Chemistry, Biology, Pharmacology, or closely related field, M.S. preferred.
Minimum of 5 years of regulatory affairs industry experience with OTC products.
Significant CMC and line management experience with demonstrable knowledge of the manufacturing and regulation of OTC pharmaceuticals.
Successful experience in negotiations with regulatory bodies and experience writing CMC documents that comply with regulatory requirements.
Ability to maintain high standards of professionalism, quality, and prioritization.
Demonstrated success negotiating with regulatory agencies such as FDA.
Trailblazing Tactics: Responsible for preparing global product CMC submissions (ANDA and market application) for pharmaceutical products (OTC) using templates for eCTD publishing.
Provide regulatory guidance to assure compliance to 21 CFR Part 314, Applications for FDA Approval to Market a New Drug and Abbreviated New Drug.
Write regulatory documents and serving as in-house regulatory expert to internal and external parties.
Provide regulatory guidance to the PLD Miami manufacturing site and providing relevant guidance and advice to expedite the manufacturing changes as needed while ensuring conditions for meeting regulatory requirements are maintained.
Work with Sales, Marketing, Creative Services, and Quality to develop, review and approve OTC Labeling consistent with 21 CFR 201.66 requirements.
Be responsible for maintaining up-to-date knowledge of regulatory affairs.
Serve as a liaison between our company and regulatory bodies such as FDA.
Manage the National Drug Code (NDC) listing requirements for the Private Label Distribution customers and PL Developments NDC listing requirements.
Perks Paradigm: HMO coverage upon regularization
Competitive Package
Hybrid work arrangement
Prime office locations
Standard government and Emapta benefits
Total of 20 annual leaves to be used on your own discretion
Fun engagement activities for employees
Mentorship and exposure to global leaders and teams
Upskilling through Emapta Academy
Career growth opportunities
Diverse and supportive work environment
Meet Your Dream Team: Collaborators Extraordinaire Our client, PL Development Holdings, stands at the forefront of the Health & Wellness sector, pioneering groundbreaking solutions in logistics and supply chain management. They specialize in delivering high-quality over-the-counter (OTC) remedies across various categories, including Analgesic, Cough/Cold, Allergy, and more. Renowned for their commitment to excellence, our client ensures the highest standards of product quality and efficiency. With a focus on innovation and customer satisfaction, they continue to lead the industry, driving advancements that positively impact millions worldwide. Join our client's esteemed team and become part of a legacy built on integrity, innovation, and relentless pursuit of excellence.
Welcome to Emapta Philippines! Discover a world of possibilities at Emapta, where your career takes flight in stability and growth. Join a team that thrives on camaraderie, supporting each other to achieve excellence together. Experience the satisfaction of being recognized for your contributions with competitive compensation packages that reflect your skills and commitment. Immerse yourself in a positive work culture that encourages collaboration, innovation, and personal development. We provide you with the platform for your success, empowering you to reach new heights in a supportive and inclusive environment.
With a wide roster of international clients from various industries and a proven track record of success, Emapta offers a stable foundation for your . Team up with like-minded professionals who are passionate about making a meaningful impact through premium global opportunities at your fingertips. Apply now and create a better future with us.
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