Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will Achieve- You will assist chemistry, manufacturing, and control (CMC) professionals with the development of CMC regulatory strategies, submissions and compliance activities for biopharmaceutical development programs and commercial products supporting the Global Pfizer Biopharmaceuticals Group Hospital and Global Brands CMC portfolio, with supervision.- Provide operational global CMC regulatory support and documentation for assigned projects/products covering clinical development, initial registrations, and approval/post approval activities of low to medium complexity/risk. Support the assembly of CMC information for submission to global regulatory agencies and supports CMC strategies with supervision. Maintain and track submission and approval status. Assist in regulatory fact finding for the preparation of CMC information for submission to global regulatory agencies. Maintain CMC systems and perform data entry.- Assist cross-functional project teams by scheduling meetings, taking meeting notes and tracking action items independently.
How You Will Achieve It-
- Manages projects, makes decisions, and executes upon strategies and plans with mínimal oversight from manager. Recommends solutions and escalates issues with significant business impact where necessary. Supports team in the development of regulatory strategies to support registrations. Demonstrates a high level of integrity in decision making on regulatory issues in line with company values.- Responsible to assist in the authoring of CMC documentation, coordination, and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control of moderate complexity with appropriate supervision.- Fosters a culture in which uncompromising integrity and accountability is the standard.- Makes decisions to resolve low to moderately complex problems in standard situations. Makes decisions within guidelines and policies and with appropriate consultation with the Team Leader.- Ability to collaborate effectively across a network of other stakeholders, partners and customers, to compile high quality CMC inputs and aiding the compliance of the Pfizer essential biopharmaceutical product portfolio. Assists in the development of resolution proposals for low to moderate regulatory CMC/information management issues in support of project/program stakeholders. Displays a willingness to make appropriate and timely decisions, exhibits sound and accurate judgment.- Ability to develop projects plans to support short-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.
Basic Qualifications
Must-Have- BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.- Minimum 3 years' work experience required.- Basic understanding of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of drug development/commercial manufacturing of pharmaceutical products with technical writing skills. Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to support others in system use.Nice to Have- Basic experience in CMC supporting clinical and post approval programs with diverse dosage forms is desirable.- Drug substance or drug product development or manufacturing technical support experience.
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs
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