Manager, Global CMC Oncology and Rare Disease

Why Patients Need You

The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.

What You Will Achieve

You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. 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 dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

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 Department.
• Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global Essential Health 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., Research and Development, Pfizer Global Supply Worldwide Strategy and Regulatory Business Units, etc.
• 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

Qualifications

Must-Have

• Bachelor's Degree
• 5+ years of experience
• Experience in Over the Counter or pharmaceutical industry, with experience in the global regulatory environment
• Regional/Country regulatory experience including submission processes and product life cycle management activities
• Knowledge of commercial activities and Current Good Manufacturing Practices (part of GxP)
• Ability to work well cross functionally and to develop productive/collaborative relationships
• Strong written and verbal communication skills

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Experience of conducting, managing or participating in the audit process

Work Location Assignment:On Premise

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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.

Regulatory Affairs