Pfizer Sr CMC Specialist in Kalamazoo, Michigan
This position is responsible for acting as a site CMC interface, in order to facilitate changes with regulatory impact. The role interfaces heavily with site personnel, as well as colleagues in Pfizer Center and individual markets, in order to assess the impact of deviations and changes, initiate regulatory changes, and provide site information for market renewals and queries. The role exists with a focus on products manufactured in Kalamazoo, having responsibility for the support of those products, globally. This position acts as the primary conduit for communication with Pfizer Center Global CMC, both using formal processes and in informal discussions. The role is often engaged in site projects, acting as the primary regulatory interface for project execution.
Initiate/Respond to regulatory changes, using the corporate regulatory change control system.
Conduct assessments of site deviations and change controls, for registration impact.
Support license renewals in global markets, through preparation and submission of site documents to Pfizer colleagues, globally.
Provide site responses to queries received from global Health Authorities.
Interact with colleagues throughout the local site, in order to develop responses to regulatory requests.
Assure that all requested information is provided within necessary timelines.
Develop strategies and outcomes for regulatory changes, in partnership with a variety of functions, both locally and globally.
Ensure communication of regulatory approvals to appropriate site personnel.
Education: BS in Chemistry, Biochemistry, Microbiology, or related science
Experience: Five years of relevant experience, particularly in quality or compliance roles
The successful candidate will have demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills. They will be able to engage colleagues globally, and will do so in a manner that recognizes the organizational and cultural differences that may exist between their partners around the world. They will also have excellent negotiation skills, and will be able to frequently resolve issues with a focus on regulatory compliance. They will have demonstrated skill in developing solutions, and will do so with a flexible approach to the development of options. Experience with regulatory changes or change control systems is preferred.
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.
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.
Last Date to Apply for Job: 5/31/18
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.