CMC Senior Regulatory Associate

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 Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and devices to meet global regulatory requirements throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, manages regulatory documents, etc. You will also be in a position to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.

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 hard work 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 projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects within a work team.
• Support the assembly of Chemistry Manufacturing and Control (CMC) information for submission to global regulatory agencies and supports CMC strategies with supervision.
• Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.
• Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
• Responsible for the preparation and finalization of Global Regulatory Strategy Documents, Clinical Data Request (CTD) sections of supplements or variations for site transfer submissions.
• Manage the maintenance of core dossiers of original applications and subsequent changes, and coordinates responses to deficiency letters, with the assistance of local and regional regulatory colleagues.
• Review and apply pertinent regulatory guidelines for authoring renewals.
• Recommend solutions and escalates issues with significant business impact.
• Manage projects independently, make decisions and execute upon strategies and plans with minimal oversight from manager.

Qualifications

Must-Have

• Bachelor's Degree
• 3+ years of experience
• Demonstrates commitment to scientific and regulatory integrity and quality compliance
• Sound understanding of regulatory processes and requirements for defined market(s) and able to interpret and apply to projects
• Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems and willingness to support others in system use
• Demonstrates a high level of integrity in decision making on regulatory issues in line with company values
• Ability to contribute to effective teams and implement change
• Makes decisions to resolve problems in standard situations
• Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systems

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Experience managing projects

Work Location Assignment:Flexible

*Last date to apply is February 15, 2023*

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