Pfizer tuyển dụng đăng ký thuốc khu vực TP Hồ Chí Minh - Vietnam Regulatory Affairs Society - Luật Dược Việt Nam, Prizer regulatory affairs manager

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Headcount number 01

Job level GL70

Working location Ho Chi Minh Effective date 1^st Jan 2018 Contract duration 1 year contractor

Job Description *Handling assigned Marketing Authorization/Licenses in Lotus project at the 1^st 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 - 1^st 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 - 1^st 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

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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