Pfizer GRA Global Regulatory Strategist in New York City, New York
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
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 that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Create and deliver strategic regulatory guidance for assigned projects/products. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines
Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects.
Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
Direct and/or indirect liaison with regulatory authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
Lead and/or participates in Regulatory Teams for assigned projects/products.
Develop and implements regulatory strategies to support/maintain registrations. Maintains product licenses across all product platforms.
Understand regulatory environment and communicates priorities to global stakeholders
Deliver project /product strategy incl. label, risk assessment, and PRS for assigned projects/products
The major duties and responsibilities will include but are not limited to:
Accountable for ensuring or contributing to Global/Regional Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.
Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities.
Partners with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, PGS, etc.) to ensure required regulatory contributions (e.g. briefing documents, line plans, IND, NDA) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.
Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated
Ensures an aligned regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated.
Works closely with other Regulatory and CMC Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning's and quality standards.
Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associationsas appropriate.
Ensures business compliance and implementation of and adherence to Regulatory standards.
Develops and maintains constructive working relationship with Health Authority contacts.
Qualifications and Skills
Bachelor Scientific Degree plus 5 years of experience
Regulatory Knowledge: Knowledge of the regulatory environment and how this impacts regulatory strategy and implementation. Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting MAAs, line extensions, NDAs, INDs. Working with and influencing, opinion leaders, external organizations facilitating approval of submissions.
Therapeutic Area Knowledge: Has working knowledge of the therapeutic area, through prior regulatory experience; direct product development and/or academic training
Commercial Awareness: Demonstrated knowledge of global regulatory procedures and requirements. Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting MAAs and post approval variations.
Problem Solving and Analysis: Strong problem identification and solving skills, e.g. risk management planning. Strong logical and analytical skills
Communication skills: Communicates effectively using a variety of mediums appropriate to the setting.
Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations
Proven examples of delivery across the product's lifecycle with demonstrable contribution in Regulatory Affairs.
Proven ability to manage complex regulatory issues.
Proven ability to consistently deliver to time, cost and quality standards.
Masters' degree plus 3 years experience
Other Job Details:
Last Date to Apply for Job:10/26/21
Additional Location Information:United States - New York - Remote
NO Relocation Package
Eligible for Employee Referral Bonus
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.
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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.
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