Associate Registration Manager

2 months ago

Beijing, Beijing, China Pfizer Full time
Job Summary

The Associate Registration Manager plays a crucial role in ensuring the regulatory maintenance of a portfolio of products. This includes preparing regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products, and clinical trial notifications, when required.

Key Responsibilities
  • Prepare 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 of China GMP, Chinese Pharmacopeia (CHP), and other China regulatory requirements in PGS sites.
  • Partner with PGS for supply strategy to avoid supply issues due to site changes.
  • Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirements, Pfizer policies, procedures, and practices.
Ensuring Regulatory Compliance
  • Ensure timely communication of the requirements of CHP and other China regulations to PGS QO and GCMC to facilitate the implementation of CHP and other regulations in PGS sites.
  • Ensure local processes are in place for the timely submission of all quality and safety-relevant variations, including labeling safety updates and specification/manufacture process changes.
Special Projects
  • Participate in special projects for the Regulatory Sciences Group.
Market Support
  • Attend Regulatory Sciences, Medical Department, and other internal meetings as required.
  • Provide a resource for other sections of the company for specified therapeutic areas.
Personal Development
  • Complete the Pfizer PRE Safety Reporting Process: Overview training module within 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 Sciences and Medical Department projects and workshops.
Qualifications/Skills

Certificates of educational background and related training certificates.

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

At least 3 years of experience in regulatory sciences working.

Strong customer focus sense.

Excellent communication and interpersonal skills.

Excellent teamwork/collaboration.

Result-oriented.

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 skills in speaking, reading, and writing.

Cultural Competencies (Leader Behaviors): Sustain Focus on Performance, Create an Inclusive Environment, Encourage Open Discussion and Debate, Manage Change, Develop People, Align Across Pfizer.

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