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Senior Associate, Regulatory Affairs

Employer
Pfizer
Location
Rocky Mount, North Carolina, United States;
Salary
Competitive
Closing date
Sep 25, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Organization Type
Pharma
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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 represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.

As a Senior 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 deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

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

How You Will Achieve It
  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Assist in developing and implementing regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defense and regulatory compliance.
  • 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.


Qualifications

Must-Have
  • Bachelor's Degree
  • 3+ years of experience
  • Industry experience in Regulatory Affairs and/or Clinical Trial Management
  • Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation
  • Proven ability to consistently deliver to time, cost and quality standards
  • Strong problem solving skills and team orientation
  • Excellent written and verbal communication skills
  • Good knowledge of Windows and Microsoft Office


Nice-to-Have

  • Master's degree
  • Relevant pharmaceutical experience
  • Awareness of and ideally experience in successfully communicating with Health Authorities
  • Familiarity with pharmaceutical organizational structures, systems, and culture


PHYSICAL/MENTAL REQUIREMENTS

Ability to communicate written and oral, work cross functionally, ability to work on teams

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to work overtime and meet stakeholders, peers etc. outside of normal hours in order to connect with other time zones

Work Location Assignment:Flexible

#LI-PFE

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.

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
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