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Regulatory Affairs Manager Brands CMC (Phase 1 to NDA)

Employer
Pfizer
Location
Ireland - Kildare - NewbridgeIreland - Cork - RingaskiddyKalamazoo, Michigan, United States;
Salary
Competitive
Closing date
Sep 25, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
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This position requires that candidates be linked to a Pfizer manufacturing or R&D site.

Why Patients Need You

We are 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 able to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.

As a manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts, and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Serve as a CMC strategist and project leader for projects within the global Brands portfolio, providing initial regulatory assessments and developing regulatory strategies with appropriate supervision.

Act as the global CMC representative, or contributes support to the global CMC representative, within cross-functional project teams, including Pharmaceutical Sciences and Co-Development teams. Accountable for assigned projects and activities, completing work within assigned product portfolio, work group/project teams, for multiple projects with supervision.

Interpret CMC regulatory requirements for human health prescription products, develops initial strategies, assess risks, and develops contingency proposals with appropriate supervision. Uses technical and scientific knowledge to conduct the initial analysis of CMC submission documentation. Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.

Responsible for 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.

Ability to collaborate effectively across a network of other stakeholders, partners, and customers, to deliver high quality CMC submissions and ensuring the compliance of the Pfizer essential pharma therapeutic portfolio. Develops initial resolution proposals for regulatory CMC/information management issues with project/program stakeholders. Displays a willingness to make decisions with appropriate input from leadership, exhibits sound and accurate judgment and makes timely decisions.

Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives with minimal supervision.

Basic Qualifications

Must-Have
  • Bachelor's Degree plus 5+ years of experience
  • Relevant pharmaceutical development, Quality Assurance/ Quality Control (QA/QC), and/or manufacturing experience
  • Minimum of 2-3 years drug substance or drug product development or manufacturing technical support experience.
  • Experience with diverse dosage forms is desirable.
  • A regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain.
  • Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.
  • Candidate is required to have a robust understanding and functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of drug development/commercial manufacturing of pharmaceutical products, including technical and scientific understanding of pharmaceutical drug development with technical writing skills.
  • Competent working knowledge of computer-based systems such as Microsoft Office,controlled documentation systems.
  • Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.
  • The candidate is required to have a clear track record of effective teamwork, collaboration, and communication, and demonstrated leadership ability in a cross-functional matrix team environment. Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes.

Nice-to-Have
  • Master's degree plus 3 years experience
  • Relevant pharmaceutical experience in injectables
  • Experience in R&D/ Quality/technical areas


ORGANIZATIONAL RELATIONSHIPS
  • Collaborates across global CMC and functional activities in a matrix environment, with globally located cross-functional project teams including representatives from diverse disciplines within the HBU organization and Pfizer Global Supply, including Pharmaceutical Sciences and Clinical.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Travel to external (trade association or agency) or internal meetings as required. The external global regulatory environment is dynamic & may demand work outside of conventional working hours and on weekends from time to time.


NO Relocation Package
Eligible for Employee Referral Bonus

#LI-PFE

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.

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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