Associate II - Reg CMC Strategy, SI Pipeline Development
Job Description
• Functions as a Global Regulatory Lead for the assigned, low to moderately complex products, and/or supports Global Regulatory Lead.
• Responsible for/supports developing global regulatory strategies, preparing and submitting the marketing authorization dossier for drug products, by self or under guidance.
• Responsible for/supports timely response to deficiencies related to marketing authorization
• Supports cross-functional teams in activities related to commercial launch.
• Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review and finalization of marketing authorization/deficiency responses, for global markets, to ensure effective data presentation and quality.
• Responsible for effective review and providing timely feedback to the cross-functional teams on technical documents related to submission (batch records, validation summaries, stability protocol/data, risk assessment reports etc.,)
• Provides regulatory assessment and supports Change Control Assessment, by self or under guidance.
• Ensures commitments (module 2-5) made to health authorities are entered into tracking systems and are tracked to closure, as appropriate.
• Provide regulatory support for the assigned products, participates and provides inputs in technical reviews and Change Control reviews as assigned.
• Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team and/or escalates to leadership team to quickly mitigate the risks, under guidance or self
• Drives resolution of issues, by self or guidance. Communicates issues, impact and outcomes to global regulatory management, team lead and core team.
• Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.
• Responsible for ensuring compliance to Company’s submission standards, policies and procedures.
Qualification and Education: M. Pharma (or other relevant science degree) with 2 to 6 Years of experience in Regulatory Affairs.
Work Location Assignment: On Premise
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.
