1+ months

Manager, GCMC Vaccines

Pfizer
Sanford, NC 27330
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**JOB SUMMARY**



+ Collaborates with departmental and cross-functional colleagues (e.g., G-CMC, GRA, WRO, and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.

+ Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.

+ Assuring product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.

+ Possession of CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.

+ Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.

+ Leveraging both technical & regulatory knowledge, to mitigate risks.

+ Delivery of high quality regulatory submissions.

+ Execution of regulatory policies and operational processes.

+ Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.

+ Execution and implementation of policies and operational processes.



**JOB RESPONSIBILITIES**



+ Develop effective relationships with local & global internal partners, i.e., R&D (PTx, BTx, PCH), PGS, GRA, BU's, etc.

+ Ensure all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.

+ Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.

+ Demonstrate ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

+ Execute training related activities (e.g., compliance-related, HR policies...), individual development plans, participate in cross-disciplinary forums & learning opportunities, engage in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.

+ Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.

+ Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.

+ Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.

+ Mentoring colleagues may be expected within focus area of expertise.

+ Manage colleagues within a GCMC function, only if the position requires supervision of personnel.

+ managing a small group of colleagues within a GCMC function, conduct performance-management & training related activities, encourage & support a healthy work/life balance, support roll-out of HR policies, assist recruitment & hiring vacancies, provide guidance & facilitate opportunities for individual development, encourage colleague participation in cross-disciplinary forums & learning opportunities, engage colleagues in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.

+ Providing guidance & direction for direct reports, managing global resources & resource capacity along with prioritizing workload appropriately.

+ Ensuring all regulatory activities within the team are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.

+ fostering & actively developing GCMC talent

+ Develop relationships with regulatory authorities to improve Pfizer's regulatory success

+ May participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to GCMC functions.

+ Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to contribute to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.

+ Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.



**QUALIFICATIONS / SKILLS**

**Education** **:**



+ Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.



**Experience** **:**



+ Technical discipline with 6+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience.

+ Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.

+ Experience operating within GMP, GLP, or GCP related SOPs.

+ Product release system exposure helpful

+ Managing colleagues within a GCMC function, only if the position requires supervision of personnel.

+ 2+ years' management & supervisory experience with technical project and/or staff.

+ Conformance/Quality experience in pharmaceutical or other regulated industry is strongly desired.

+ Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.

+ Strong understanding of CMC change management processes and CMC CTD content/structure.

+ Advanced skills in written & oral communications are mandatory.

+ Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.

+ Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools

+ Prior experience managing projects is preferred.

+ Lean and/or SixSigma experience helpful.



**DESIRED/REQUIRED COMPETENCIES**

**Decision Making**



+ Acts Decisively

+ Solves moderately complex problems within area of expertise

+ May aid with solving problems outside of own department.



**Impact of Decisions**



+ Decisions impact primarily own Department's short term objectives

+ Decisions impact multiple Sub Business Unit/Sub Operating Units mid-term objectives

+ Significant or long-term decisions are reviewed by senior management



**Risk Management**



+ Ability to recognize and address risks across projects and programs.



+ Manages regulatory risks & ambiguous situations under limited supervision.



**Innovation/ Creativity**



+ Investigates novel and unconventional approaches to address issues and solve problems.

+ Identifies existing process/product improvements and may take appropriate risks to develop innovative ideas/processes/ products and advance new concepts that improve the department's work processes/products.



**Scientific & Regulatory Leadership**



+ Ability to develop and/or lead projects or team initiatives to support short-term operational goals.

+ Ability to think globally across zones and divisions.

+ Ability to influence at the work group/discipline project team level.



**Knowledge Breadth and Depth / Sharing**



+ Demonstrates technical/functional expertise in applicable discipline and acquires knowledge in related disciplines

+ Provides technical/functional guidance/oversight to subordinates within the department

+ Demonstrates strong industry knowledge and comprehensive understanding of business processes.

+ Begins to acquire fundamental business expertise

+ Actively shares knowledge with others within Department through existing knowledge sharing processes/systems.



**Teamwork/ Collaboration**



+ Ability to contribute to effective teams & implement change.

+ Aptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.



**Communication**



+ Communication & Negotiation skills

+ Creates or leverages existing communication materials and information to aid Work Team in delivering goals/objectives.

+ Contributes to the development of, and often delivers, presentations within the Department.

+ Demonstrated good verbal and written communication skills.



**Vision, Strategy, and Business Alignment**



+ Establishes operational activities/projects that support mid-term goals and set direction for the Sub Business Unit/Sub Operating Unit.

+ Oversees operational activities/projects of professional Work Teams to support short-term Department goals.



**Influencing Others**



+ Manages teams that execute direction for the Sub Business Unit/Sub Operating Unit.

+ Solicits input and explains difficult concepts and persuades others to adopt a point of view.



**Managing Change**



+ Recognizes initiates and manages change that impacts the Department.



**People Management**



+ Recognizes others' need for development and collaborates with individuals to create a development plan

+ Is accountable for general effective people management and development.

+ Guides direct reports on relevant experiences to meet career objectives.

+ Manages the performance of direct reports through goal setting, ongoing assessment and coaching.

+ Guides direct reports on relevant experiences to meet career objectives.



**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.



**Other Information**



+ Additional Location Information: Massachusetts - Andover, Missouri - St. Louis, New Jersey - Peapack Pennsylvania- Collegeville & New York - Pearl River

+ Eligible for Employee Referral Bonus



**\#LI-PFE**

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-09-24 Expires: 2019-11-28

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Manager, GCMC Vaccines

Pfizer
Sanford, NC 27330

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