Senior 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 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 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.

How You Will Achieve It

T he Regulatory Affairs Senior Associate assists in the definition of US regulatory requirements and review of data submitted by project team members. Geographical scope is focused on the United States.

• Assembles, prepares and/or reviews and submits original registrations, amendments, supplements, variations, maintenance reports and other documents to FDA in line with US regulatory requirements and guidelines.
• Prepares responses to action letters and other agency requests.
• Provides regulatory advice and support to assigned products/teams.
• Identifies and communicates registration needs and strategies.
• Evaluates manufacturing, procurement, compendial, and labeling changes for regulatory impact and accurately describes these changes for ease of regulatory agency review.
• Maintains awareness of applicable regulations.
• With oversight, serves as a liaison with regulatory agencies pertaining to assigned products/teams.
• Assists in the preparation of Agency meeting packages and strategies for agency meetings.
• 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.
• 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.
• Support the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local/regional level.
• Work with the team managers to effectively forecast and manage project specific resources utilizing flexible resourcing and global load sharing as normal business practice.
• Operate as Subject Matter Expert in dossier types and processes with responsibility for training and mentoring fellow colleagues.
• Escalate, inform, and resolve any issues that may impact submission builds or the logistics of submission delivery to Health Authorities.
• 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.
• 3+ years of experience in quality assurance/compliance, regulatory affairs or research and development or related area.
• Knowledge or experience filling FDA submissions.
• Scientific background via formal education and/or previous work experience.
• Relevant experience in electronic submissions build within the Pharmaceutical Industry.
• Strong knowledge of the drug development process, regulatory affairs, and submission management.
• Understanding of systems and electronic technologies used to support submission and planning activities.
• Attention to detail and exceptional organizational skills.
• Proven experience managing or delivering through others in a team environment.
• Proficient in English, verbal and written.
  
  

Nice-to-Have

• Familiarity with pharmaceutical organizational structures, systems, and culture
• Presents scientific data effectively, in verbal and written in a logical and persuasive manner
• Experience in project management
  
  

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

Not applicable

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Potential travel: 5%

Flexibility to accommodate early or late meetings with global partners.

Last Date to Apply for Job: May 25th, 2021

Eligible for Relocation Package: NO

Eligible for Employee Referral Bonus: YES

#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