16 days old

/ Associate Regulatory Affairs Manager

Pfizer
Beijing
**Identifying Job Information**

**JOB TITLE:** ( Title reflected Pfizer Org Chart )

Associate Regulatory Affairs Manager

**REPORTS TO:** ( Manager Title )

Regulatory TA Lead

**DIVISION/BUSINESS LINE:**

Global Product Development

**VERSION DATE:**

15-Sep-2020

**SUB DIVISION:**

Global Regulatory Affairs/ Global Regulatory Affairs-International

**DEPARTMENT NAME:**

China Regulatory Affairs, Pfizer Biopharmaceuticals

**LOCATION(S):** ( indicate Pfizer locations )

Beijing, China



**JOB INFORMATION**

**JOB SUMMARY**

Summarize the primary purpose & key accountabilities of the job.

The Associate Registration Manager assists with the regulatory maintenance of a portfolio of **vaccine** products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. The Associate Registration Manager will assist the line Managers on specific projects, and in some instances will be responsible for their own projects. The Associate Registration Manager ensures that each project operates within the set timeframes, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Pfizer Standard Operating Procedures. The Associate Registration Manager may also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.



**JOB RESPONSIBILITIES**

Indicate the primary responsibilities critical to the job.

Collaborate and Communicate with China PBG President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:

I. Responsibilities



+ Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.

+ Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data.

+ Develop an overall perspective of registration projects.

+ Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.

+ Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.

+ Maintain and update the Local Product Document (labeling) and Artwork in accordance with relevant regulations and Pfizer SOPs

+ Maintain an up to date knowledge of the relevant legislation in China.

+ Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.

+ Provide regulatory advice to company personnel as required.

+ Partner with the global regulatory and clinical development team in China PBG BUs for new products development strategy and inline products strategy.

+ Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.

+ Partner with PGS for supply strategy to avoid supply issue due to site changes

+ Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices



II. Ensuring Regulatory Compliance



+ Ensure timely communicate the requirement of CHP and other China regulations to PGS QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites

+ Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and specification/manufacture process change



III. Special Projects



+ Be required to participate on special projects for the Regulatory Affairs Group



IV. Market Support



+ Attend Regulatory Affairs, Medical Department and other internal meetings as required.

+ Provide a resource for other sections of the company for specified therapeutic areas.



V. Personal Development



+ Complete the Pfizer PRE Safety Reporting Process: Overview training module in the set timeframe.

+ Complete related Training.

+ Attend and actively participate in personal development courses as required.

+ Attend training in specific therapeutic areas as required.

+ Participate in Regulatory Affairs and Medical Department projects and workshops.



**QUALIFICATIONS / SKILLS**

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

**Certifications**

Certificates of Educational background and related training certificates.

**Education**

Tertiary qualifications in pharmacy or a science degree with a pharmacology major.

**Experience**

At least 3 years experience in vaccine regulatory affairs working.

**Technical**



+ Strong Customer focus sense

+ Excellent communication & interpersonal skills

+ Excellent Teamwork/collaboration

+ Result orientated

+ Quality orientation

+ Excellent ability to research information

+ Able to work under pressure in a busy environment

+ Good working knowledge of international and local regulatory guidelines and codes

+ Good working knowledge of Microsoft Word, PowerPoint and Excel

+ Excellent English skill in speaking, reading and writing



**Managerial**

Cultural Competencies (Leader Behaviors)

Sustain Focus on Performance

Create an Inclusive Environment

Encourage Open Discussion and Debate

Manage Change

Develop People

Align Across Pfizer



**ORGANIZATIONAL RELATIONSHIPS**

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.

Collaborates with Midical, MI, CTM, Clinical Pharmacology, Clinical Development, Clinical Statistics, Safety etc.



**RESOURCES MANAGED**

Summary of resources managed.

May supervise contracted resources and external consultants on specific projects.

May have matrixed role on specific projects.



\#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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/ Associate Regulatory Affairs Manager

Pfizer
Beijing

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