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

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Prizer regulatory affairs manager
Prizer regulatory affairs manager
Pfizer tuyển dụng đăng ký thuốc khu vực TP Hồ Chí Minh
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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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