Pfizer

Regulatory Sr. Manager, Chemistry, Manufacturing, Controls (CMC)

Employer
Pfizer
Location
Peapack, New Jersey
Salary
Competitive
Posted
September 09 2021
Ref
4823070
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager
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 represent Pfizer as an Approval Liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the Regulatory Liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments, and periodic experience reports.

As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges, and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.

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

How You Will Achieve It
  • Develop ideas and lead/co-lead complex projects across division, and develop and manage plans to achieve objectives.
  • Ensure regulatory conformance & consistency globally in compliance with external regulatory requirements and internal quality procedures.
  • Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
  • Develop effective relationships with local & global internal partners, i.e., Research and Development, Pfizer Global Supply Worldwide Strategy and Regulatory Business Units, etc.
  • Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global Essential Health portfolio, providing regulatory assessments and developing regulatory strategies with minimal supervision.
  • Lead the preparation of CMC information for submission to regulatory agencies, generate CMC strategies, assesses risks and develops contingency plans, including major, complex applications.
  • Execute training related activities {e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums & learning opportunities.
  • Demonstrate and model adherence to all Pfizer behaviors & values, embrace and comply with Global Chemistry Manufacturing and Controls Principles of Integrity.
  • Serve as a technical and scientific resource within own work group and provide guidance for completion of difficult and complex projects.



Qualifications

Must-Have
  • BS/BA Degree plus 9+ years of experience
  • Drug substance or drug product development or manufacturing technical support experience
  • Experience in regulatory Chemistry Manufacturing and Control (CMC) or with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain
  • Good level of knowledge and solid understanding of the development and commercial activities, and (Current) Good Manufacturing Practices (part of GxP) required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s)
  • Ability to learn and navigate tracking/change control systems, and willingness to train and support others in system use
  • Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities
  • Strong interpersonal and leadership skills
  • Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systems


Nice-to-Have
  • MS/MA/MBA degree 7 +years experience
  • Relevant pharmaceutical experience
  • Experience managing projects
  • Experience with diverse dosage forms, particularly sterile products


  • This job is a US/PR Exempt Grade: 014


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.

Other Job Details:

Last Date to Apply for Job:09/15/21
Additional Location Information:United States - New Jersey - Peapack; Ireland - Dublin - Grange Castle; United States - Connecticut - Groton; United States - Massachusetts - Andover; United States - Missouri - St. Louis - Chesterfield; United States - North Carolina - Sanford; United States - Pennsylvania - Collegeville

NO 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