Deputy Manager/CRL support – Regulatory Affairs

  • Company:
    Pfizer Inc.
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    1 week ago
  • Category:
    Biotechnology/Pharmaceutical/Medicine | Manufacturing/Industrial

Skill: regulatory submission , regulatory , regulatory affairs; Exp: 0-3 years; Committed to quality and excellence in compliance and conformance Accountable for maintaining the corporate change and dossier management system regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and policies. Ensures timely communication of any issues e.g. Board of Health queries to the regional teams as needed Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process. MRP/Decentralised / National MAA Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations. Centralised MAA Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations. Populate and Maintain Regulatory Databases Responsible for database entry and the document management of regulatory transactions undertaken at local level. Responsible for database entry and archival of regulatory material required at local level Contribute to Good Regulatory Practice (appropriate for all tasks) Adhere to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained. Through maintenance of regulatory activities in line with company procedures for own products, contribute to inspection ready state of Regulatory Department and wider business Support Regulatory Affairs Group Development Contribute to and support as necessary, the maintenance and development of the Regulatory Affairs group through pro-active involvement and participation and in some instances, leading of special projects; e.g. development of new operating procedures. Support drive towards Pfizer/PEH RA Vision and Values. Support development of regulatory colleagues by sharing relevant knowledge and experience. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Drug Regulation

Degree: 

Experience: 0-3

Function: Biotech / Pharma / R&D