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Sr. Associate, PEH GRA Biosimilars

Pfizer


Location:
Collegeville, PA 19426
Date:
11/22/2017
2017-11-222017-12-23
Pfizer
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Job Details

**ROLE SUMMARY**



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.







**ROLE RESPONSIBILITIES**



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 in preparation of regulatory strategies and identification of regulatory requirements for submissions to insure the efficient approval and registration of products. Evaluates manufacturing, labeling and promotional material changes for regulatory impact with guidance.







**QUALIFICATIONS**



Bachelor's degree in chemistry, biochemistry, pharmacy or related field required. 3-5 years previous experience in the Regulatory Affairs preferred. Experience in DMFs, eCTD and the ability to work with CMS required. Understanding of biological molecules, including proteins and antibodies required.







**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.







**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.







Last day to apply: Tuesday, November 28, 2017







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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