Associate, Regulatory Affairs
- Employer
- Pfizer
- Location
- Lake Forest, Illinois; Rocky Mount, North Carolina
- Salary
- Competitive
- Posted
- January 20 2021
- Ref
- 4796606
- Discipline
- Other, Legal/Regulatory Affairs
- Position Type
- Full Time
- Organization Type
- Pharma
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.
ROLE SUMMARY
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.
ROLE RESPONSIBILITIES
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Potential travel: 5%
Hours may need to be adjusted to accommodate overlap with global partners.
Other Job Details:
Eligible for Employee Referral Bonus
#LI-PFE
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
#LI-PFE
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.
ROLE SUMMARY
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.
ROLE RESPONSIBILITIES
- 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 manufacturing, labeling and promotional material changes for regulatory impact with guidance.
BASIC QUALIFICATIONS
- A Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject is required.
PREFERRED QUALIFICATIONS
- 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
Potential travel: 5%
Hours may need to be adjusted to accommodate overlap with global partners.
Other Job Details:
Eligible for Employee Referral Bonus
#LI-PFE
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
#LI-PFE