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
- Toàn thời gianFULL_TIME
Đã hết hạn 7 years ago
2017-05-14T16:00:00+00:00Công việc đã đóng.
Miêu Tả Về Công Việc
- 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).
Trình độ tối thiểu
- 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.
Đặc quyền và lợi ích
Flexitime
Kỹ năng cần thiết
- Medical Industry Knowledge
- Attention to Detail
- Critical Thinking
Bằng cấp và Giấy chứng nhận
- Pharmacist
Khóa học ưa thích
- Pharmacy
Tóm tắt công việc
- Trình Độ Công Việc
- Phó Giám Sát/Giám Sát
- Ngành Nghề
- Health and Medical
- Yêu cầu học vấn
- Tốt nghiệp Cử nhân
- Nhà tuyển dụng trả lời hồ sơ
- Sometimes
- Địa chỉ văn phòng
- Unit 802 Pioneer Highlands South Condominium Tower 1, Pioneer St corner Madison St, Mandaluyong City, Mandaluyong, National Capital Region, Philippines
- Ngành nghề
- Contracted Sales Outsourcing
- Vị trí đang tuyển
- 2 vị trí tuyển dụng mới
- Trang web
- https://www.tmpi.com.ph
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Về 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::