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Regulatory Affairs Manager, CMC

Employer
Pfizer
Location
McPherson, Kansas
Salary
Competitive
Closing date
May 20, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
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

You will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for sterile injectable product facility changes to meet global regulatory requirements throughout the life cycle. You will be developing briefing regulatory strategy documents to support facility related changes. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory commercial and post-approval submissions. You will help in 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 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.

Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports. You will also serve as the site interface during regulatory site inspections acting as the point person.

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 division.
  • Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the Sterile Injectables portfolio, providing regulatory assessments and developing regulatory strategies with minimal 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., Global Product Development, Pfizer Global Supply, Global Regulatory Affairs Business Units.
  • 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.
  • Liaise with and provide input/direction to Global Chemistry Manufacturing and Controls, and any other key stakeholder to ensure the filing strategies for initial registrations and the lifecycle submissions are defined and executed and the BoH requirements are met, ensuring a submission ready dossier.
  • Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.


Qualifications

Must-Have

  • Bachelor's Degree plus 5+ years of experience
  • Demonstrable experience of effective delivery in a complex matrix environment
  • Regulatory experience including knowledge of New Drug Application (NDA)/ANDA, and lifecycle submissions.
  • In depth knowledge of national/regional regulatory legislation and guidelines
  • Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
  • Leadership qualities and management skills, team oriented with problem solving skills
  • Strong written and verbal communication and inter-personal skills


Nice-to-Have

  • Master's degree plus 3 years experience
  • Relevant pharmaceutical experience


Other Job Details:

Last Date to Apply for Job:05/20/2022

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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