Pfizer Regulatory Strategist (Director) in New York City, New York
The purpose of this role is to:
Create and deliver strategic regulatory guidance for assigned NCE level projects/products, with an appropriate level of independence. 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 Health Authorities (in conjunction with PCOs) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.
Develop and implement regulatory strategies in support of new submissions and to maintain registrations. Maintain product licenses across all product platforms.
Understand regulatory environment and communicate priorities to global/regional stakeholders
Deliver project/product regulatory strategy, risk assessment, and PRS for assigned projects/products
The major duties and responsibilities will include, but are not limited to:
Developing or contributing to Global/Regional regulatory strategies and implementation plans (including core labels, risk registers) developed for assigned projects/products, with an appropriate level of independence.
Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, and minimize resource demands while optimizing overall project delivery time and probability of success and facilitating post-filing activities.
Partnering with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, PGS, etc.) to ensure required regulatory contributions (line plans, IND, NDA, MAA, etc.) meet business needs and are provided to the project teams, in accordance with agreed time, cost and quality standards.
Developing and maintaining constructive working relationships with Health Authority contacts.
Delivering the project/product regulatory goals and aligning the regulatory strategy with global/regional business needs.
Ensuring regulatory plans are monitored, progress/variance is communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) is mitigated
Developing fit-for-purpose submission packages in collaboration with partner lines
Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are championed and communicated.
Working closely with other Regulatory Strategists and CMC Team within and across clusters/TAs and sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
Engaging in appropriate activities in order to influence the regulatory environment through Health Authority contacts, Pfizer Country Office partners and trade associations as appropriate.
Ensuring business compliance and implementation of and adherence to regulatory standards.
B.S. Scientific Degree required.An advanced Scientific Degree (Ph.D., PharmD., M.D., and M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.
Proven experience in managing global and/or regional regulatory and registration activities involved in the drug development process, especially at the NCE level as well as post-marketing lifecycle management, preferably in Regulatory Affairs/Health Authority and/or a proven track record of success in negotiating with Health Authorities and in representing interests to internal and external stakeholders.Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable.
In depth and relevant Global and/or Regional regulatory experience
Experience in managing complex regulatory issues and/or business processes
Proven ability to consistently deliver to time, cost, and quality standards
Proven ability to lead virtual teams in creating successful relationships with Medical, Commercial, Safety, other Regulatory colleagues, and other partner lines to achieve objectives
Experience in successfully communicating with major Health Authority (ies), including leading and participating in such interactions, is preferred.
Knowledge of assigned therapeutic areas/disease areas is preferred
Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
Proven ability to deliver in a highly matrixed organization.
Excellent written and verbal communication skills
Ability to work well independently with minimal direct supervision
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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.
N (Other) (United States of America)
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