Director- Advisory Office

ROLE SUMMARY

The Director of Advisory Office (AO) CMC is a senior leader position in the AO/ CMC organization. This position would require an analytical background / leadership role, providing direction/ consult on CMC regulatory- science and risk based strategy (primarily Analytical focused) in support of small molecule programs (and grow to large molecule). This role would primarily be project/ portfolio support focused; with an external advocacy component targeting benefits for Pfizer through influencing and expediting internal implementation of new regulations and guidelines, etc. The role would include, but limited to, expertise in dissolution, impurities, methods, ICH (for example Q2/14, Q12), etc.

ROLE RESPONSIBILITIES

• In coordination with the CoDev Team and the GCMC Product Lead and Line Management, help develop and critically review the regulatory strategy for CTDs, Briefing Packages and BoH Queries associated with the analytical components of the submission, including specifications, analytical methods and their validation, stability (including purposeful degradation), and the dissolution strategy.
• Provide additional project support as a GCMC (Advisory Office) contributor to various subject matter expert groups, such as the Dissolution Advisory Council and the (Groton) Impurity Council, as well as any ad hoc limited-duration SME groups that arise (e.g., Strategic Framework for Dissolution Development, Q2/14, etc.).
• Primarily through the IQ Consortium's Analytical Leadership Group and associated workgroups (in partnership with ARD PSSM/ BTX) advocate on behalf of Pfizer in key advocacy areas: change management (ICH Q12), analytical methodology development (ICH Q14) and clinically relevant dissolution methods and specifications. This is accomplished by participation in workshops, publication of papers associated with these topics and providing (and sometimes coordinating) Pfizer commentary on relevant draft regulatory guidance.
• Contribute articles to, and periodically publish, the QRP Newsletter, and at times collate or coordinate Pfizer SME responses to key emerging regulatory guidance.
• Contribute to the strategic direction of the QRP through the QRP Steering Committee and other QRP initiatives
• Exercising & maintaining engagements / relationships with regulatory authorities
• Leadership 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 (PSSM BTx, PCH), PGS, WSR, BU's, etc.,
• 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.
• May serve as GCMC lead of a core project portfolio (multiple projects) and/or Due Diligence exercises.
• 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.
• Developing relationships with regulatory authorities to improve Pfizer's regulatory success
• Demonstrating ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

BASIC QUALIFICATIONS

Doctorate degree or equivalent experience preferred in a pharmaceutical (Analytical or related science) &/or technical discipline.

PREFERRED QUALIFICATIONS

• Technical discipline with 12+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 8+ years pharmaceutical regulatory experience.
• Recognized as a technical subject-matter expert with extensive relevant regulatory experience & business knowledge, a leader and strategist capable of leading 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.

#LI-PFE

Other Job Details
Eligible for Employee Referral Bonus

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