Pfizer tuyển dụng đăng ký thuốc khu vực TP Hồ Chí Minh

3037
Prizer regulatory affairs manager
Prizer regulatory affairs manager
5/5 - (1 bình chọn)

TUYỂN DỤNG ĐĂNG KÝ THUỐC PFIZER

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Thông tin liên hệ:

Chị Loan: loan.huynhthanh@pfizer.com or Điện thoại 0918208817

Headcount number 01
Job level GL70
Working location Ho Chi Minh
Effective date 1st Jan 2018
Contract duration 1 year contractor
Job Description
  • Handling assigned Marketing Authorization/Licenses in Lotus project at the 1st stage and extend more SKUs in the future if required, including:

– Develop regulatory strategy

– Harmonize dossier quality of local products vs Pfizer standard

– Co-coordinator between regulatory team of local partner & Pfizer regional regulatory & Health Authorities to develop the submission package, follow up the registration status & get approval.

– Coordinate with local commercial to retain supply continuity

– Work with Health Authority to handle regulatory issues

– 1st 6 months: 50% time, then 70%

  • Handling promotional materials for whole PEH portfolio:

– Oversight pro-mat registration

– Develop pro-mat registration framework: requirements, process, stakeholder map.

– Do pro-mat registration works including:

+ Support MKT to filing pro-mat registration dossier

+ Coordinate both with RA team in Hanoi to get DAV’s feedback & support MKT/Medical teams in HCM to prepare the supplement pro-mat dossier.

+ Work with RA team in HN to get pro-mat approval

– 1st 6 months: 50% time, then 30%

  * Other tasks to support RA (if any)
   
Organizational relationship –          Subordinate: 0

–          Superior: Regulatory Affairs Lead

–          Internal stakeholder :

o  Colleagues in the Marketing Department

o  Medical

o  Public Affairs & Market Access

o  Logistics; Procurement

o  Business Development

–  External stakeholder:

o  DAV

o  Local partner

Qualification –          BS in Pharmacy or Doctor

–          3-5 years of experience in Regulatory in pharmaceutical industry

–          Experience at Manager level is preferable

–          Good knowledge on regulations and regulatory environment

–          Experience working with MoH

–           Ability to take initiative and work autonomously without significant direction

–          Project management, time management and influence skills

–          Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization, partners, and authority

–          Good English

 

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Ngày viết:
Vietnam Regulatory Affairs Society. Join us, VNRAS, feel free to contact. We'll provide you all information and regulatory affairs update related to products covered by the Ministry of Health of Vietnam (drug, vaccine, biological, pharmaceutical raw material, excipient, capsule, traditional medicine, herbal medicine, medical equipment, invitro diagnostic medical devices, cosmetic, food supplements, chemical and preparation for medical and household use).
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