15 days old

Sr. Regulatory Policy Manager

Pfizer
Beijing
Job Description

This position is responsible for the capturing, distribution, assessment and advocacy of the regulatory policy/regulations for Greater China Region (China mainland, HK, TW).



+ Monitor regulatory environment and providing policy impact analysis and strategic access plan.Timely and proactively collect regulatory regulations, coordinate RA internal assessment and feedback to the HA or the relative association. Keep effective communication with external/internal partners, and timely providing regulatory policy position paper and briefing aligned with RALT. Develop and execute the policy shaping and advocacy strategy and plan which are aligned with RALT and AZ position. Utilize the varied platforms to enable the HA engagement programs.



+ Role as regulatory policy expert to provide the training and interpretation internally and externally.

+ Be the company/RA representative in the assigned WG or TF of the industry association to cooperate for the policy/regulatory assessment and advocacy Work closely with industry associations, Chamber of Commerce, working groups, International Exchange Center, Standard Committee, etc., participating and coordinating the relevant meetings and events.

+ Develop the RP process or system and continuing improvement regulatory strategy:

+ Deeply understand the policy & regulatory changes, anchor the strategy & impact analysis to business and new projects

+ Support RA Head and RA LT on the assigned regulatory policy & RA strategy related projects **JOB RESPONSIBILITIES** Indicate the primary responsibilities critical to the job.



+ Adherence to Pfizer Upjohn and industry code of conduct, ethics and good regulatory practices including RA SOPs and other required SOPs.

+ Align with the values and vision of Pfizer Upjohn

+ Maintain regulatory compliance with Local legislation, Global regulatory policies

+ Maintain company confidentiality (i.e. intellectual property, product information and strategic information)

+ Follow SOP requirements especially on documentation

+ Monitor regulatory environment and providing policy impact analysis and strategic access plan

+ Establish/maintain the process/database for the intelligence collection

+ Arrange the regulatory intelligence/policy assessment meeting and take the meeting minutes

+ Coordinate the consultation with external parties if any for the policy assessment

+ Draft the assessment report based on the discussion internally and the consultation with the external party if any

+ Coordinate the review to report and share with the key stakeholders in a regular basis.

+ Keep effective communication with external/internal partners

+ Effective internal cross-functional communication within key stakeholders for identifying technical topics.

+ Timely providing regulatory policy position paper and briefing

+ Timely collect authority regulatory regulations, coordinating RA internal discussion and feedback to relative department.

+ Work closely with industry associations, Chamber of Commerce, working groups, International Exchange Center, Standard Committee, etc., participating and coordinating the relevant meetings and events.

+ Exert external influence to shape the environment.

+ Contribute on BD projects to deliver the regulatory strategy, assessment and timeline



+ \#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Regulatory Affairs

Categories

Posted: 2020-10-13 Expires: 2020-11-12

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Sr. Regulatory Policy Manager

Pfizer
Beijing

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