Associate, Global Regulatory Affairs

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The Regulatory Affairs Associate assists in the definition of global regulatory requirements and review of data submitted by project team members. Assembles and prepares regulatory submissions and other regulatory documents to regulatory agencies. The role reports to the Director Global Regulatory Affairs located in our north suburban Chicago/Lake Forest, IL offices.

Yourknowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• With oversight, collaborates with other functional areas to obtain documentation for regulatory purposes.
  
• Seeks expert advice and technical support as required. Ensures accuracy and completeness of all information.
  
• Assembles, prepares, and submits original registrations, amendments, supplements, variations, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements and guidelines.
  
• Prepares responses to action letters and other agency requests.
  
• Assists manager in preparation of regulatory strategies and identification of regulatory requirements for submissions to insure the efficient approval and registration of products.
  
• 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, minimizing development costs and cycles.
  
• Define and negotiate regulatory strategy with supervision.
  
• Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
  
• Provides daily regulatory support to new product development teams and commercial plant support with guidance.
  
• Participates in preparing regulatory strategies. Reviews major submissions, regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution
  

Qualifications

Must-Have

• A Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject is required.
  
• Good interpersonal skills.
  
• Good oral and written communications skills.
  
• Developing negotiating skills.
  
• Developing understanding of business needs
  
• 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.
  
• Exercise good judgment within policy and regulations.
  

Nice-to-Have

• Scientific background via formal education and/or previous work experience is a plus.
  
• Two to three years of experience in quality assurance/compliance, regulatory affairs or R&D area preferred
  

Other Job Details:

• Last Date to Apply for Job: Monday July 18th 2022.
  
• Eligible for Employee Referral Bonus
  
• Work Location Assignment: Flexible
  

Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.

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

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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