Regulatory Affairs Pharmacist
Leading Edge Executive Talent Search Inc.
- Makati, Philippines22nd Floor, 139 Corporate Center, Valero Street, Salcedo Village, Makati, Metro Manila, PhilippinesMakatiMetro ManilaPhilippinesPhilippines
- Full timeFULL_TIME
Job closed.
Job Description
The position is responsible for ensuring compliance with all of the regulations and laws pertaining to Company’s ethical and supplement products. Regulatory Affairs Pharmacists/Officers are the crucial link between the Company, its products and regulatory authorities. Duties and responsibilities are as follows:
Regulatory Affairs
- Responsible for the Company’s compliance with all of the regulations of BFAD and other related regulatory authorities;
- Liaises with, and makes presentations to regulatory authorities
- Develops and writes clear arguments and explanations for new product licenses and license renewals
- Negotiates with regulatory authorities to ensure marketing authorization for products;
- Ensures all Certificate of Product Registrations (CPRs) and licenses are renewed on time by proper submission of license requirements and renewals to strict deadlines
- Properly monitors and sets timelines for license requirements and renewal approvals; keeps an updated CPR data base
- Keeps abreast of changes in regulatory rules and guidelines that would impact the Company’s products and business operations
- Attends to FDA audit and ensures compliance to audit findings if there are non-compliances
- Collates and ensures correctness and completeness of dossier products for initial registration
- Responsible for initial and renewal registration protocol to FDA and makes necessary follow-ups on the registration status of the product/s
- Prepares compliance documents to FDA Notice of Deficiencies (NODs) in coordination with the toll manufacturer
- Implements proper destruction and disposal of expired or rejected and returned goods
- Conducts periodic audit in toll manufacturer
- Coordinates with toll manufacturers any developments or changes on regulatory requirements
- In case of product recall, coordinates with toll manufacturer and FDA during the whole process up to the completion of recall
- Plans, undertakes and oversees product trials and regulatory inspections
- Makes recommendations to Management on the disposition of returned products whether for resale or sample, for reprocess or for destruction and disposal
- Provides strategic recommendations and/or advice to senior management throughout the development of a new product
- Handles requirements for labelling, storage and packaging
Supply Chain Management and Production
- Makes recommendation to improve productivity, quality/efficacy of products taking into consideration the market impact and business viability of the products
- Coordinates preparation of Purchase Orders for approval of CFO and/or President-CEO based on production requirements
- Coordinates with printers on the development of promotional and packaging materials, including correctness of labels and boxes according to FDA labelling requirements
- Assigns barcode number to new products and coordinates with GS1 Philippines
- Updates inventory record of raw and packaging materials as well as finished products
- Conducts annual physical inventory of all materials stored at the manufacturer’s warehouse, in coordination with Accounting and third party auditor
- Prepares claims/complaints against courier when there are damages on Finished Goods in transit
- Evaluates accreditation of suppliers in coordination with the toll manufacturer
- Coordinates with the manufacture on Purchase Orders (POs) and makes necessary follow ups on the timely delivery of finished goods
- Prepares quarterly and yearly production forecast based on approved Sales forecast
- Regularly reviews the production forecast based on actual movement of products
- Minimizes shortages and keeps the costs down.
Sales Support
- Researches and prepares product knowledge materials for the training and re-training of Medical Sales Representatives
Other Tasks
- Other tasks and assignments that may be assigned from time to time
Minimum Qualifications
- Licensed Pharmacist
- At least 1-year experience of working in the field of Regulatory Affairs is an advantage
- Keen to details, highly motivated, flexible, and with a sense of urgency
- Good written and verbal communication skills
- Willing to work in Alabang
- Fresh Graduates are welcome to apply
Jobs Summary
- Job Level
- Entry Level / Junior, Apprentice
- Job Category
- Health and Medical
- Educational Requirement
- Bachelor's degree graduate
- Recruiter response to application
- Once in a while
- Office Address
- 22nd Floor, 139 Corporate Center, Valero Street, Salcedo Village, Makati, Metro Manila, Philippines
About Leading Edge Executive Talent Search Inc.
Recruitment Process Outsourcing (RPO) Group is a division of Leading Edge Executive Search, Inc. providing RPO and professional staffing services to local & multinational clients from various business sectors.
Our team comes with an expertise honed from being experienced staffing professionals and corporate recruiters -- working hard to deliver good matches to our clientele.