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Regulatory Manager Chemistry, Manufacturing, Controls (CMC)

Company: Pfizer
Location: Peapack
Posted on: June 10, 2021

Job Description:

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 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

  • Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the Department.
  • Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global Brands portfolio, providing 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 PGS site, 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.
  • Responsible for the development 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.
  • Contribute to global Chemistry Manufacturing and Controls projects, initiatives & actions along with prioritizing assigned workload appropriately.
  • Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
  • Develop effective relationships with local and global internal partners, i.e., Research and Development, Pfizer Global Supply, Worldwide Strategy and Regulatory Business Units, etc.
  • Leverage both technical and regulatory knowledge, to mitigate risks.
  • Execute regulatory policies and operational processes and delivery of high quality regulatory submissions.
  • Use technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.

Qualifications

Must-Have

  • Bachelor's Degree or equivalent scientific/engineering/pharmaceutical development sciences degree, plus 5+ years of experience
  • Relevant pharmaceutical development, Quality Assurance/ Quality Control (QA/QC), and/or manufacturing experience, with a minimum of 2-3 years drug substance or drug product development or manufacturing technical support experience
  • Demonstrated commitment to scientific and regulatory integrity, quality compliance
  • CMC (Chemistry Manufacturing and Control) regulatory and quality expertise to prepare regulatory assessments, develop and contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle
  • Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio
  • 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
  • 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
  • Excellent planning, organizational and project management skills
  • Advanced skills in written and verbal communications
  • Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systems

Nice-to-Have

  • MA/MBA/MS plus 3+years experience; or a PhD/PharmD/JD degree.
  • Project management experience with planning/organizing by prioritizing and planning work activities and change agility
  • Relevant pharmaceutical experience
  • Experience with diverse dosage forms

PHYSICAL/MENTAL REQUIREMENTS

Normal office based and needs to be able to travel on public transport, including international.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional business travel

Other Job Details:

Last Date to Apply for Job: 06/09/21

Additional Location Information: United States - New Jersey - Peapack; United States - Connecticut - Groton; United States - Pennsylvania - Collegeville; United States - Michigan - Kalamazoo

NO Eligible for Relocation Package

Eligible for Employee Referral Bonus

#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

#LI-PFE

Keywords: Pfizer, Newark , Regulatory Manager Chemistry, Manufacturing, Controls (CMC), Other , Peapack, New Jersey

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