Regulatory Pharmacist

San Mateo, Rizal

Posted 30 days ago


Company:: EDL Group of Companies
Company Description:: EDL Group of Companies is a conglomerate (EDL Holdings, Inc.) engaged in trading, marketing, distribution, manufacturing of veterinary products, animal vaccines, and conditioning. It has animal farms engaged in animal breeding and production such as pekin ducks, fighting cocks, pigeons, livestock, eel, including canine training. In the recent years, it has diversified to other industries such as organic food growing, restaurants, event’s place and farm resort development, agri-farm tourism, media and publishing, printing, animal wellness and diagnostic, and beauty and wellness (for humans). Dr. Eulalio D. Lorenzo, the founder of EDL Group of Companies remains humble to this day, despite his success and building a conglomerate that helps elevate the standards of Philippine agriculture. His company, East Asia Laboratories, Inc. is the first-Filipino-owned that ventured into animal vaccine production. Dr. Lorenzo started his first venture, East Asia Veterinary Products, Inc. (EAVP) in 1993. EAVP provided animal nutrition and veterinary products to commercial farms and integrators. After a year, he established Excellence Poultry & Livestock Specialist, Inc. (EPLS) that caters to poultry supply outlets nationwide and game farms. Today, EPLS has expanded to more divisions such as the Pet Options for small animals and Rockdove/Pigeons It has also ventured to international distribution of its products. Business expansion As Doc Ayong started to develop other products intended for poultry (game fowl, pigeons), swine, cattle, dogs; driven by his determination and armed with business acumen, he established East Asia Laboratories, Inc., which became the manufacturing arm of the company that develops local medicines, supplements and vaccines for animals such as gamefowls, pigeons, poultry, livestock and small animals. Soon after, Doc Ayong put up other companies like Animal Genetics Improvement and Agri-Resources, EDL Exemplar Builders and Development Corporation, EDL Printing and El Dia General Merchandise. Pitgames Magazines, Inc., an independent publishing company owned by Mr. Manny Berbano, became a partner of EDL. In 2014, New Generation Animal Health Products, Inc. (NGAHPI) officially opened, which became the marketing and distribution company of products for commercial farms and Pork Champ. This year, 2019, NGAHPI Company will become East Asia Veterinary Products, Inc. again. Towards the latter part of 2014, Dr. Lorenzo ventured into beauty and wellness named Mc Dell Healthcare Products, Inc.(a distributor of Korean Farmstay products). Farm resorts, restaurants and event’s place were simultaneously developed. Estancia de Lorenzo, a farm resort and event's place, officially opened its services to the public in December 2015. Doc Ayong also opened his EDL Agri-Tourism Farm in Capas, Tarlac known as The Farmhouse. EDL Animal Healthcare and Technical Services (Vet & Lab City) also opened in Cubao last 2017. EDL Group of Companies is continuously expanding its entire organization. Fresh talents have started their careers in EDL Group while more experts in their respective skills have joined EDL Group of Companies to help make EDL Group of Companies the organization of choice.
Contract Type:: Contract
Experience Required:: 2 years
Education Level:: Bachelor’s Degree
Gender:: Any
Number of vacancies:: 1

Job Description

Job description
The position requires at least a graduate of BS Pharmacy or any other related course. He/she must have a good understanding of the interactions between the company's various regulatory and GMP requirements. He/she must be able to manage his/her time and projects in order to meet deadlines while complying with the quality objectives. An excellent data management skill is necessary, as well as a first-rate communication efficiency.

Job Summary:

The Documentation and Regulatory Officer is responsible for maintaining the Company's Archives. He/she prepares, issues and keeps all manufacturing process documents. Documenting complaints and recalls is also his/her responsibility. He/she is also responsible for product registrations, license renewals, periodic updates, and registrations to regulatory agencies.

Duties and Responsibilities:

Prompt issuance of manufacturing records and forms to insures smooth flow of production schedules.
Advise departments on document management process.
Verify that documents conform to the company standards prior to release.
Receive and process documents from all departments.
Register, index and classify documents in the document management system.
Record, publish and notify as to the availability and update of all documentation.
Participate in establishing procedures, guidelines and forms.
Collect and coordinate information and prepare regulatory documentations for submission to regulatory agencies or to commercial partners.
Advise on the regulatory agency submission strategy.
Timely compile materials for license renewals, updates and registrations.
Maintain regulatory files/database and chronologies in good order.
Establish and maintain system for tracking changes in documents submitted to agencies or partners.
Review (proof) labeling and label for compliance with regulatory requirements.
Maintain knowledge of FDA, BAI, PDEA, etc. and international regulation, guidance and standards applicable to company products.