at Pfizer in Lake Forest, Illinois, United States
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. Geographical scope is primarily Country/Region focused. Assembles, prepares and/or reviews regulatory submissions and other regulatory documents to regulatory agencies.
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
+ Assembles, prepares and/or reviews and submits original registrations, amendments, supplements, variations, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements and guidelines.
+ 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.
+ 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
+ Evaluates CMC, manufacturing, labeling and promotional material changes for regulatory impact with guidance.
+ A Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject is required.
+ Good knowledge of English, spoken and written
+ Two to three years’ experience in quality assurance/compliance, regulatory affairs or research and development or related area.
+ Scientific background via formal education and/or previous work experience.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Other Job Details:
+ Last Date to Apply for Job: 13 APRIL 2023
+ Eligible for Employee Referral Bonus
+ NOT Eligible for Relocation Assistance
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.
Relocation assistance may be available based on business needs and/or eligibility.
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.
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.