Associate II - Regulatory CMC Strategy - Brands CMC
Job Description
Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post- approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists –CMC (GRSs-CMC) under the guidance of the team lead. The activities include the following, but not limited to:
- Ensures effective coordination and collaboration with GRS-CMCs and the regional regulatory leads to ensure key submission deliverables for the assigned projects to the team.
- Responsible for end to end CMC contribution for the assigned projects; Reviews the assigned regulatory activities including the related technical/supportive information/ documents for completeness and accuracy; Responsible for development of initial global regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC; Responsible for authoring and/or compiling Regulatory Strategy Documents (RSD) where needed; Responsible for authoring of CMC content in Module 1, Module 2.3, M3.2.S/P/R as agreed upon with the GRS CMC within agreed timelines.
- Responsible for identification and communication of identified risks to the GRS CMCs and/or appropriate leadership, also proposes mitigation strategy with the support of team lead; Ensures resolution of issues and manages regulatory risks within project.
- Reviews and applies pertinent global regulatory guidelines. Exhibits technical / functional expertise and provides strategies on regulatory requirement, negotiates with and influences the cross functional teams, colleagues and external partners to ensure regulatory data requirements are met.
- Coordinates with the respective team for M3.2.R Ancillary documents
- Represents HBU GRA CMC point of view and meets with key stakeholders to resolve challenges.
- Coordinates internal document review and sign off.
- Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.
- Supports Query and/or commitment management in collaboration with GRS CMCs.
- Maintains conformance systems maintenance in support of the GRS CMCs
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs#LI-PFEPfizer 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.
