GCMC_APAC_Sr.Associate
Pfizer Canada Inc.
Makati City, Philippines
9d ago
  • Collaborates with departmental and cross-functional colleagues (eg. G-CMC, WSR, WRO, and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug, dietary supplement and cosmetic development or manufacturing lifecycle.
  • Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.
  • Assuring product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
  • Possession of CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug, dietary supplement and cosmetic development or manufacturing lifecycle.
  • Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.
  • Leveraging both technical & regulatory knowledge, to mitigate risks.
  • Delivery of high quality regulatory submissions.
  • Execution of regulatory policies and operational processes.
  • Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.
  • Technical and / or other job-related skills :

  • Sufficient level of knowledge in development & commercial activities and cGMP’s is required.
  • An understanding of regulatory requirements & expectations and criteria for submission & approval globally.
  • Demonstrated commitment & dedication to scientific & regulatory integrity & quality
  • Technical and / or other job-related skills :

  • Sufficient level of knowledge in development & commercial activities and cGMP’s is required.
  • An understanding of regulatory requirements & expectations and criteria for submission & approval globally.
  • Demonstrated commitment & dedication to scientific & regulatory integrity & quality
  • Conformance / Quality experience in pharmaceutical, dietary supplement or other regulated industry is strongly desired.
  • Advanced skills in written & oral communications are mandatory.
  • Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
  • 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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