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Regulatory Affairs Senior Associate CMC

Ireland - Kildare - NewbridgePeapack, New Jersey, United States;Groton, Connecticut, United States;
Closing date
Oct 6, 2022

View more

Other, Legal/Regulatory Affairs
Position Type
Full Time
Organization Type
All Industry, 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
  • As a Senior Associate, you will assist CMC professionals with the development of CMC regulatory strategies, submissions and compliance activities for biopharmaceutical development programs and commercial products supporting the Global Pfizer Biopharmaceuticals Group Hospital Category portfolio, with supervision.
  • Provide operational global CMC regulatory support and documentation for assigned projects/products covering clinical development, initial registrations, and approval/post approval activities of medium complexity/risk. Support the assembly of CMC information for submission to global regulatory agencies and supports CMC strategies with supervision. Maintain and track submission and approval status. Assist in regulatory fact finding for the preparation of CMC information for submission to global regulatory agencies.Maintain CMC systems and perform data entry.
  • Assist cross-functional project teams by scheduling meetings, taking meeting notes and tracking action items independently.

How You Will Achieve It
  • Sound understanding of regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Aware of external regulatory environment, including competitor intelligence and regulatory actions to assist regulatory strategy development. Able to identify inconsistencies and deficiencies in technical data and escalates to management for resolution. Assesses scientific opinions in developing regulatory strategies and documentation. Knowledge of drug development practice, rules, regulations, and guidelines. Demonstrates a developed knowledge of key processes, procedures, and tools. Maintains compliance in regulatory systems.
  • Independently manages projects, makes decisions, and executes upon strategies and plans with minimal oversight from manager. Recommends solutions and escalates issues with significant business impact where necessary. Supports team in the development of regulatory strategies to support registrations. Demonstrates a high level of integrity in decision making on regulatory issues in line with company values.
  • Responsible to assist in the authoring of CMC documentation, coordination, and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control of moderate complexity with appropriate supervision.
  • Actively participates in trade associations.
  • Fosters a culture in which uncompromising integrity and accountability is the standard.
  • Makes decisions to resolve moderately complex problems in standard situations. Makes decisions within guidelines and policies.
  • Understands the fundamental business drivers for the company. Uses this knowledge in own work.
  • Ability to collaborate effectively across a network of other stakeholders, partners and customers, to compile high quality CMC inputs and aiding the compliance of the Pfizer essential biopharmaceutical product portfolio. Assists in the development of resolution proposals for moderate regulatory CMC/information management issues in support of project/program stakeholders. Displays a willingness to make appropriate and timely decisions, exhibits sound and accurate judgment.
  • Ability to develop projects plans to support short-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.

Basic Qualifications

  • BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree preferred.
  • Minimum 1-2 years work experience required.
  • Basic understanding of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of drug development/commercial manufacturing of pharmaceutical products with technical writing skills. Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to support others in system use.
  • The candidate ideally should have experience with effective teamwork, collaboration, and communication, and demonstrated leadership ability. Project management along with planning/organizing by prioritizing and planning work activities and change agility are desirable attributes.Adaptability and self-motivation, able to prioritize effectively with strong problem solving and planning abilities.

Preferred Qualifications
  • MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree
  • Experience in CMC supporting clinical and post approval programs with diverse dosage formulations is desirable.


Limited Travel outside of standard work schedule.

Last Date to Apply for Job: August 19th, 2022

Eligible for Employee Referral Bonus: YES


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
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