Regulatory Affairs Specialist I
Training and Marketing Professionals Inc
- Mandaluyong, PhilippinesUnit 802 Pioneer Highlands South Condominium Tower 1, Pioneer St corner Madison St, Mandaluyong City, Mandaluyong, National Capital Region, PhilippinesMandaluyongNational Capital RegionPhilippinesPhilippines
- Full timeFULL_TIME
Expired 7 years ago
2017-05-14T16:00:00+00:00Job closed.
Job Description
- WSR Sharepoint Maintenance.
- This is the local repositiory of:
- Other regulatory related activities such as tender bidding.
- FDA certifications/letters
- Deficiency notices/letters
- Variation applications
- Label submissions and approvals
- Product history profile
- Market authorizations
- Assist in the updating the system through data collection and uploading documents.
- Total product licenses to be monitored and tracked is 234 (combined LPFE and LHSP).
- This is the local repositiory of:
- GMP Clearance Sharepoint Monitoring.
- This is local repository of local and foreign manufacturers.
- Assist in updating the system to ensure that all manufacturers have valid GMP.
- Inform manufacturers ahead of any near expiring GMP certification.
- Request for new GMP certificates or proof of renewal.
- For FDA requirement on Foreign GMP Clearance.
- Track the validity of the FDA certification.
- Handle the request of documents via CST.
- Prepare application to FDA for renewal of GMP clearance.
- Total number of manufacturers: foreign is 32 and local (to be determined).
- GLE monitoring - stands for Generic Labelling Exemption.
- This applies of take-out pack or "as-is" pack or international packaging, where the company is allowed to import and distribute goods up to 12,000 units per year per packaging per dosage strength.
- GLE and CPR validity is aligned.
- Ensure that GLE for duly approved prior to expiration.
- Total number of 69 (combined LPFE and LHSP).
Minimum Qualifications
- Licensed Pharmacist.
- At least 3 years of experience with regulatory affairs work.
- Strong analytical and planning skills.
- Good communication and presentation skills.
- Excellent problem-solving skills.
Perks and Benefits
Flexitime
Required Skills
- Medical Industry Knowledge
- Attention to Detail
- Critical Thinking
Licenses and Certifications
- Pharmacist
Preferred Courses
- Pharmacy
Jobs Summary
- Job Level
- Associate / Supervisor
- Job Category
- Health and Medical
- Educational Requirement
- Bachelor's degree graduate
- Recruiter response to application
- Sometimes
- Office Address
- Unit 802 Pioneer Highlands South Condominium Tower 1, Pioneer St corner Madison St, Mandaluyong City, Mandaluyong, National Capital Region, Philippines
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About Training and Marketing Professionals Inc
Training and Marketing Professionals Inc. (TMPI) is a Sales and Marketing service provider. TMPI was organized by sales and marketing professionals who previously worked together in one of the biggest multinational pharmaceutical and nutritional company in the Philippines.
The people behind TMPI has a combined 80 years of experience in sales, marketing and training, imbued with the zeal, passion and a burning desire to pursue what they love doing over the years, the company TMPI was finally incorporated in August 2003.
TMPI in its humble beginning started operations with 10 reps, 1 supervisor and 1 back office support. With pride, TMPI today has grown to over a 300 head-strong service provider company executing various high-impact programs nationwide for our valued clients which include the biggest and industry leaders like::