Job Details

Manager Regulatory CMC Oncology and Rare Disease

Company name
Pfizer Inc

Location
Raleigh, NC, United States

Employment Type
Full-Time

Industry
Healthcare, Pharmaceutical

Posted on
Jan 21, 2023

Valid Through
May 06, 2023

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Profile

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 division.

Provide strategic regulatory input into WRS global regulatory strategies, thus providing optimal support for meeting local business objectives under Country Regulatory Head lead.

Train Pfizer Consumer Healthcare Worldwide Strategy and Regulatory team on Pfizer systems and ensure integration into regional work processes.

Responsible for the co-ordination of translations for core documents required for submission.

Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.

Support regulatory compliance activities with monitoring and reporting compliance in all critical points required of Worldwide Strategy and Regulatory systems.

Maintain licenses in compliance with local regulations by ensuring that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place.

Collaborate with HUB colleagues to ensure support is appropriately aligned with local High Availability requirements, maintain constructive relationship with HUB and proactively seek continuous improvement in HUB processes.

Manages the compilation for core package build, contributing to (Clinical Trial Application) CTA and authoring documentation.

Update and check recorded/newly entered data regularly and in timely manner according to the standard operation procedures/guidelines.

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: 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.

Regulatory Affairs

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