What are the responsibilities and job description for the Director Regulatory CMC Strategy position at Pfizer?
ROLE SUMMARY
The Director of GCMC is a senior level position in the GCMC organization. This is an individual contributor role, providing direction on CMC regulatory strategy for a range of small molecule programs under the Sr Director’s jurisdiction.
ROLE RESPONSIBILITIES
- Exercising & maintaining engagements / relationships with regulatory authorities
- Participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to GCMC functions.
- Cultivating sustainable & effective relationships with internal partners, i.e., R&D (PTx, BTx, PCH), PGS, WSR, BU’s, etc.,
- Lead and/or contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
- Demonstrating ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
- May serve as CMC representative on Project Teams and/or Pfizer project governance bodies & steering committees to achieve consensus for GCMC strategies.
- Leads regulatory programs for a portfolio of projects with minimal oversight.
- Prepares regulatory strategy assessments
- Leads collaboration within & across divisions, working with other scientific & technical leaders, to establish aligned approaches to regulatory strategies and/or policies.
- Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
- Demonstrating ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
BASIC QUALIFICATIONS
- Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.
- Technical discipline with 8-12 years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 6 years pharmaceutical regulatory experience.
PREFERRED QUALIFICATIONS
- Recognized as a technical subject-matter expert with extensive relevant regulatory experience & business knowledge, a leader and strategist capable to lead interactions with regulatory agencies for assigned projects and programs. One whom exercises independence in judgment and decision-making principles to influence regulatory & business strategy, guiding complex projects with broad impact and balancing risk with organizational flexibility & business needs
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.
Work Location Assignment: Flexible
Relocation assistance may be available based on business needs and/or eligibility.
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.
Salary : $83,800 - $106,000
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