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    Manager, Cmc

    Pfizer
    5+ years
    Not Disclosed
    Beijing
    10 Nov. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Summary

    Collaborate with cross-functional teams (e.g., GRS-CMC, RA, Pharm Sci, and PGS) to integrate technical and regulatory knowledge, align expectations, and manage planning and monitoring activities to mitigate risks. Contribute to global regulatory strategies, ensuring timely and efficient regulatory submissions across all stages of drug development and manufacturing lifecycles.

    Key Responsibilities:

    • Deliver high-quality regulatory submissions.
    • Maintain and update CMC product information, market registration details, and component-level dossiers. Ensure compliance with regulatory change management processes.
    • Assure product compliance through timely updates of CMC submission documentation in regulatory systems.
    • Develop and contribute to global regulatory strategies with management's assistance, covering all aspects of drug development or manufacturing.
    • Stay updated on regulatory conformance and compliance with external regulatory requirements and internal quality procedures.
    • Mitigate risks by leveraging technical and regulatory knowledge.
    • Implement regulatory policies and operational processes effectively.
    • Contribute to cross-functional and strategic initiatives aimed at addressing gaps, mitigating risks, and improving regulatory conformance.

    Job Responsibilities:

    • Serve as the primary China GRS-CMC representative for core projects, providing CMC support for clinical trial applications, NDAs, and post-approval variations.
    • Ensure high-quality CMC submissions in compliance with China’s regulations and guidelines.
    • Effectively manage regulatory issues and track submission information and regulatory commitments in relevant GRS-CMC systems with minimal supervision.
    • Prioritize and manage GRS-CMC projects and initiatives.
    • Act as a scientific/technical resource, articulating issues for resolution and ensuring effective project execution.
    • Participate in training activities, compliance-related initiatives, HR policies, and cross-disciplinary forums to foster continuous learning and adherence to Pfizer's values.
    • Build effective relationships with local and global internal teams such as GRS-CMC, China RA, DC, and PGS.

    Technical Skill Requirements:

    • Sufficient knowledge of development and commercial activities, along with an understanding of cGMPs.
    • Familiarity with China, US, and EU regulatory requirements for submissions and approvals.
    • Strong commitment to scientific and regulatory integrity, with an emphasis on quality compliance.
    • Knowledge of CMC business processes related to drug development and partnering organizations is a plus.
    • Proficiency in both written and oral communication in Chinese and English.
    • Computer literacy in Microsoft Office Suite, Documentum-based applications, and other data management tools.
    • Experience with document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum).

    Qualifications:

    • Education: BS, MS, or PhD degree in chemistry, biology, or related scientific disciplines (Advanced degree preferred).
    • Experience: 5+ years in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing, or R&D) and at least 2+ years in pharmaceutical regulatory affairs.

    Desired / Required Competencies:

    • Ability to act decisively and manage regulatory risks and ambiguous situations under supervision.
    • Ability to contribute to team initiatives supporting short-term operational goals.
    • Ability to work in teams, implement changes, and approach challenges with enthusiasm and integrity, despite demanding workloads and deadlines.

    Work Location Assignment: Hybrid

    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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