1+ months

Senior Associate, Regulatory Affairs

Pfizer
Lake Forest, IL 60045
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**ROLE SUMMARY**

The Regulatory Affairs Senior 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.



**ROLE RESPONSIBILITIES**



+ Assembles, prepares and/or reviews and submits supplements, variations, drug master files, amendments, 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.

+ Provides regulatory advice and support to assigned products/teams.

+ Identifies and communicates registration needs and strategies.

+ Evaluates manufacturing, procurement, and compendial changes for regulatory impact and accurately describes these changes for ease of regulatory agency review.

+ Maintains awareness of applicable regulations.

+ With oversight, serves as a liaison with regulatory agencies pertaining to assigned products/teams.

+ Assists in the preparation of Agency meeting packages and strategies for agency meetings.



**BASIC QUALIFICATIONS**



+ A Bachelor's Degree in engineering, pharmacy, biology, chemistry, pharmacology, engineering or related subject is required.

**PREFERRED QUALIFICATIONS**



+ Three to five years' experience in quality assurance/compliance, regulatory affairs, technical support or research and development or related area.

+ Scientific background via formal education and/or previous work experience.

+ Experience in drug container closure systems, drug-device combination products or US Type III drug master files



**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.

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-06-07 Expires: 2019-08-10

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Senior Associate, Regulatory Affairs

Pfizer
Lake Forest, IL 60045

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