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Chaoyang Qu, Beijing Shi 100096
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Job Details

Position Purpose

The Sr. Regulatory Affairs Manager is responsible for the regulatory maintenance of portfolio products and regulatory approval of new products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial approvals. The SRAM is also responsible for the specific registration projects to ensure that each project operates within the set timeframes and conducts in accordance with local regulatory agency requirements and relevant Pfizer SOPs.

Supervising and coaching subordinates if necessary; Build up strong relationship with relevant government agency and keep closely contact with corporate supporting team

The role will take a special focus on multiple therapeutic area designated to him to her. This will require the SRAM to maintain a global overview of the therapeutic areas, in respect of the Company's products, competitor products and treatment standards. Thus providing this expertise to the clinical develop and medical group as well as to other Company personnel where required.

Ensure optimal regulatory compliance in China.

Primary Responsibilities

Collaborate and Communicate with China GEP and GIP 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:

1. New Drug and Inline Products Registration Planning &; Implementing for the therapeutic area of AI products.

1.1 Set up new product registration plan, prepare the regulatory submissions for registration of new products, variations and renewals to marketed products and clinical trial applications, where required

1.2 Critically analysis data packages for regulatory compliance and identify discrepancies in data presented and request additional data

1.3 Develop an overall perspective plan of registration projects

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

1.5 Maintain and update the Local Product Document (labeling) in accordance with relevant regulations and PPG SOPs

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

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

1.8 Provide regulatory advice to company personnel as required

1.9 Partner with the global regulatory and clinical development team in GIP/GEP BUs for new products development strategy and inline products strategy.

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

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

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

2 Build-up Relationships with Both Relevant Government Agencies and Corporate Supporting Teams, Ensure Compliance with the Regulations and Expedite Approvals

2.1 Well understand regulations and build up a platform to communicate with officials

2.2 Provide necessary and timely supports to policy team for all the policy advocacy activities

2.3 Efficiently use company resource to enhance the working relationship with relevant government agencies and building strong company image

2.4 Actively collect information and monitor the change of regulatory environment;

2.5 Strengthen the liaison with corporate support teams via various tools or communication channels during daily operation

3 Ensuring Regulatory Compliance

3.1 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

3.2 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

4 Special Projects

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

5 Marketing Support

5.1 Attend Regulatory Affairs Department, new product development , Medical and other internal meetings as required

5.2 Provide a resource or supports for other sections of the company for specified therapeutic areas

6 People Management &; Team Work Spirit

6.1 Demonstrate and influence the team on leadership behavior and core value in daily work, in terms of coaching and developing people; information/ best expertise sharing; positive and constructive way of communication (frank, honest, friendly etc)

6.2 Ensure effective communications between Regulatory Affairs Department and other functional teams within company.

7 Personal Development

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

7.2 Attend and actively participate in personal development courses as required

7.3 Attend training in specific therapeutic areas as required.

7.4 Lead Regulatory Affairs, Clinical development and Medical Department projects and workshops

Technical Skill Requirements

1. Ability Functional

1.1 Organizing and planning

1.2 Communication and interpersonal skill

1.3 Team spirit

1.4 Good sense in the area

1.5 Problem solving

Computer skill

2. Cultural Competencies (Leader Behaviors)

2.1 Sustain Focus on Performance

2.2 Create an Inclusive Environment

2.3 Encourage Open Discussion and Debate

2.4 Manage Change

2.5 Develop People

Align Across Pfizer

Qualifications (i.e., preferred education, experience, attributes)

Educational /Training

Bachelor degree or above in Pharmaceuticals, Pharmaceutical chemistry, Medical, Biologic or related sciences with a pharmaceutical major

2Working Experiences

2.1 At least 8 years experience in Chinese regulatory affairs working at a high level of competency

2.2 Independently lead a team with multiple therapeutic areas for at least 2 years

2.3 Experience in more than one therapeutic areas

2.4 Good working knowledge of international and local regulatory guidelines and codes.

2.5 Fluent in English both in written and speaking, Proficiency in basic computer skills including Basic Microsoft Word, PowerPoint and Excel and familiarity with use of databases.

N: Not Applicable - (China)

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