Senior Regulatory Affairs Associate, Clinical Safety and Labelling Management

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.

Provides regulatory support and expertise by developing global regulatory strategies for labelling and clinical/nonclinical submissions, identifying needed registration data, obtaining this data and ensuring that it is effectively presented to regulatory agencies. May serve as a lead regulatory representative to an assigned product or project team.

• Provides regulatory advice and support to assigned products/teams on clinical and labeling regulatory requirements. Identifies and communicates regulatory data needs and strategies. Maintains awareness of applicable regulations.
  
  
• With support from manager, leads the preparation of labeling, nonclinical/clinical regulatory information for submission to global regulatory agencies, generates and drives required strategies, assesses risks and develops contingency/mitigation plans.
  
  
• Acts as the Global Regulatory representative responsible within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic labeling, clinical decisions and other sections of the dossier.
  
  
• With support from manager, coordinates the preparation and review of registration packages and responses to deficiency letters to ensure effective data presentation and quality. Uses technical and scientific knowledge to conduct the analysis of submission documentation. Resolves issues and manages regulatory risks within cross functional project teams.
  
  
• Contributes to the development of internal policies, processes and procedures.
  
  
• Ensures business compliance and implementation of/adherence to Regulatory standards.
  
  
• Works closely with peers within, and across, sites to align processes, systems, working practices, and quality standards.
  
  
• Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.
  
  
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
  
  
• Interpret global regulations and assure regulatory compliance.
  
  
• Define and negotiate regulatory strategy with supervision.
  
  
• Exercise good judgment within policy and regulations.
  
  
  

BASIC QUALIFICATIONS

• Bachelor's Degree - Degree in pharmacy, biology, chemistry, pharmacology, or related subject.
  
  
• 3-5 years of experience in Regulatory Affairs, Research, Development or related area.
  
  
• Good oral and written communication, negotiating skills and capability in understanding business needs.
  
  
• Provides daily regulatory support to labelling and clinical cross-functional teams with guidance.
  
  
• Participates in preparing regulatory strategies. Reviews regulatory submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
  
  
• Acts independently on all routine issues, makes judgment and executes.
  
  
• Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues.
  
  
• Presents scientific data effectively orally and in writing in a logical and persuasive manner.
  
  
  

PREFERRED QUALIFICATIONS

• Master's Degree
  
  
  

OTHER QUALIFICATIONS

• Last date to apply July 11, 2022
  
  

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

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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.

Regulatory Affairs