Associate Registration Manager

2 weeks 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 involves preparing regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products, and clinical trial notifications, as required. The successful candidate will assist line managers on specific projects and, in some instances, be responsible for their own projects. The Associate Registration Manager ensures that each project operates within 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.

Key Responsibilities

The Associate Registration Manager will be responsible for:

  • Preparing regulatory submissions for registration of new products, variations to marketed products, and clinical trial applications, where required.
  • Critically analyzing data packages for regulatory compliance and identifying discrepancies in data presented and requesting additional data.
  • Developing an overall perspective of registration projects.
  • Preparing responses to deficiency letters and ensuring that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.
  • Maintaining contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations, and expedite approvals.
  • Maintaining and updating the Local Product Document (labeling) and Artwork in accordance with relevant regulations and Pfizer SOPs.
  • Maintaining an up-to-date knowledge of the relevant legislation in China.
  • Maintaining adequate product knowledge to ensure prompt and professional responses to queries relating to company products.
  • Providing regulatory advice to company personnel as required.
  • Partnering with the global regulatory and clinical development team in China PBG BUs for new products development strategy and inline products strategy.
  • Partnering with PGS and Pharma Sciences for the implementation of China GMP, Chinese Pharmacopeia (CHP), and other China regulatory requirements in PGS sites.
  • Partnering with PGS for supply strategy to avoid supply issues due to site changes.
  • Providing regulatory inputs for the approval of promotional materials following applicable regulatory requirements, Pfizer policies, procedures, and practices.

Ensuring Regulatory Compliance

The Associate Registration Manager will 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.
  • 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

The Associate Registration Manager may be required to participate in special projects for the Regulatory Sciences Group.

Market Support

The Associate Registration Manager will:

  • 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

The Associate Registration Manager will:

  • 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

The successful candidate will possess:

  • 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)

The successful candidate will demonstrate:

  • Sustain Focus on Performance.
  • Create an Inclusive Environment.
  • Encourage Open Discussion and Debate.
  • Manage Change.
  • Develop People.
  • Align Across Pfizer.

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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