Pfizer Inc. Regulatory Senior Associate Chemistry Manufacturing Controls CMC in Collegeville, Pennsylvania
Reference #: 4702529 ROLE SUMMARY Assist CMC professionals with the development of CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting the Essential Health Business Unit with supervision. Provide operational global CMC regulatory support and documentation for assigned projects/products covering initial registrations and approval/post approval activities of medium complexity/risk. Supports the assembly of CMC information for submission to global regulatory agencies and supports CMC strategies with supervision. Maintains and tracks submission and approval statuses. 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 notes and tracking action items independently. Opportunity to increase level of complexity and independence with potential career path of global CMC strategist. RESPONSIBILITIES Sound understanding of regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Aware of external regulatory environment, including competitor intelligence and regulatory actions to assist regulatory strategy development. Able to identify inconsistencies and deficiencies in technical data and escalates to management for resolution. Assesses scientific opinions in developing regulatory strategies and documentation. Knowledge of drug development practice, rules, regulations, and guidelines. Demonstrates a developed knowledge of key processes, procedures and tools. Maintains compliance in regulatory systems. Independently manages projects, makes decisions and executes upon strategies and plans with minimal 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 ... For full info follow application link. EEO & 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, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.