In this role, you will support and oversee multiple projects and ongoing work activities of moderate complexity within the department. You will operate in a highly cross-functional environment, partnering closely with stakeholders across Research & Development and Vaccines, to ensure regulatory deliverables are completed on time, in compliance with current regulatory guidance, and in a full, submission-ready format.
ROLE RESPONSIBILITIES
- Support projects of all levels of complexity (task-related) and take joint accountability for deliverables, or lead less complex projects/workstreams within the department.
- Partner closely with cross-functional stakeholders to drive execution of deliverables.
- Ensure project compliance with global regulatory standards by effectively contributing and influencing team decisions.
- Ensure regulatory deliverables are completed on time, in compliance with current regulatory guidance, and in full submission-ready format.
- Performs submission-ready quality review.
- Ensures documents align with current regulatory guidance and internal standards, confirming accuracy, consistency, completeness, and submission-ready formatting.
- Independently execute assigned tasks and deliverables, making well-defined, data-informed decisions in conjunction with direct line manager or more senior colleagues.
- Explore and propose ideas for process improvements within the confines of existing SOPs and guidance documents, raising new ideas for risk assessment.
- Foster a culture of innovation by developing scientific activities that support strategic goals.
- Identifies and addresses interpersonal or process conflicts within the immediate team, focusing on quick, practical solutions and escalating when necessary.
- Apply problem-solving skills to advance project development while maintaining high regulatory compliance.
BASIC QUALIFICATIONS
- BA/BS with at least 4 years of experience, an MBA/MS with at least 2 years of experience.
- Extensive knowledge of regulatory and quality assurance in the pharmaceutical or vaccine industry.
- Strong understanding of global regulatory requirements and guidelines.
- Proven track record in project management within a regulatory or scientific setting.
- Experience in reviewing regulatory documentation.
- Ability to analyze and interpret scientific data to support regulatory submissions.
- Proficient in risk assessment and mitigation strategies related to vaccine development.
- Familiarity with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)
- Excellent organizational skills and attention to detail.
- Proficiency with document authoring and review tools (e.g., Microsoft Word advanced features) and regulated document management systems
PREFERRED QUALIFICATION
- Experience in leading cross-functional teams
- Strong problem-solving and critical-thinking skills.
- Effective communication and presentation skills.
- Ability to build and maintain strong relationships with internal and external stakeholders Experience supporting vaccine development programs and reviewing study reports.
- Demonstrated leadership and people management skills.
- Adaptability and resilience in a dynamic work environment.
- Strong negotiation and conflict resolution abilities.
PHYSICAL/MENTAL REQUIREMENTS
N/A
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Available to work overtime when necessary to meet urgent timelines.
Work Location Assignment:Remote
The annual base salary for this position ranges from $88,500.00 to $147,500.00. In addition, this position is eligible for participation in Pfizer27s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life27s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site 2D U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Regulatory Affairs
