Associate, Regulatory Affairs

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.

What You Will Achieve

You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.

As an Associate, your knowledge 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 submissions on time. Your innovative use of communication tools and techniques will facilitate in addressing difficult issues and establishing consensus between teams.

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

The Regulatory Affairs Associate assists in the definition of U.S. regulatory requirements and review of data submitted by project team members. Geographical scope is primarily U.S. focused. Assembles, prepares and/or reviews regulatory submissions and other regulatory documents to regulatory agencies. The primary responsibility for the role is support of submission of all in-scope annual reports by the required date to US FDA.

How You Will Achieve It

• Assembles, prepares and/or reviews and submits in-scope annual reports to US FDA in line with US 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.
• Facilitates engagement with global teams that support authoring and publishing activities.
• Aid in compilation of metrics to ensure continuous improvement.
• Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
• Able to follow scientific arguments and ensure data is complete and sound.
• Ensure maintenance of product and license information in the tracking database.
• Responsible for curriculum and training assignments.

Qualifications

Must-Have

• A Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject is required.
• Proficient in English, verbal and written
  
  

Nice-to-Have

• 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.
• Attention to detail and exceptional organizational skills
• Presents scientific data effectively, in verbal and written in a logical and persuasive manner
• Proven experience delivering through others in a team environment
• Relevant pharmaceutical experience
• Familiarity with pharmaceutical organizational structures, systems, and culture

Other Job Details:

• Eligible for Relocation Package: NO
• Eligible for Employee Referral Bonus: YES
• #LI-PFE

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