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Regulatory Officer
2 weeks ago
Job description:
We seek a Pharmacist who has a profound interest in and passion for the various functions in regulatory that include product registration, implementation of regulatory affairs rules and procedures, handling of appropriate licensing, marketing and legal compliance of VMV products around the world.
Patience, perseverance, and a commitment to excellence are required to meet our exacting standards, as well as a creative, out-of-the-box problem solver with irreproachable ethics. A highly organized mind who is meticulous about rules, procedures and documentation is needed for this position—but this detail-obsessed employee must also know how to pleasantly and effectively work with and negotiate several internal stakeholders as well as FDA authorities.
This person must be able to quickly and profoundly master FDA regulations so as to be able to comply with them strictly as well as understand the variabilities that allow for other, but always ethical and legal, interpretations and applications.
Responsibilities:
- Secure LTO for the company as exclusive distributor in the Philippines and/or other licenses or permits as required.
- Assist in the registration of products; helps in the management, monitoring, and renewal of appropriate certificates, licenses, and permits.
- Serve as liaison between Marketing and various departments and/or companies regarding research and development, product evaluations, usage testing, and other technical requirements of products and services.
- Ensure the fulfillment of FDA Requirements
- Ensure proper registration and management of the registration (renewal, updating, etc.) of products.
- Research product registration requirements in other markets.
- Ensure proper registration of products in the US (drugs and cosmetics) and provide regulatory support to the Global Market for other market registrations.
- To assist training or co-facilitate training on CRM.
Qualifications:
- Graduate of Pharmacy
- Must be a registered Pharmacist
- 1-2 years relevant work experience as a Regulatory Specialist/Officer.
- Knowledgeable in FDA regulations
