Pfizer Regulatory Strategist, Senior Manager in New York City, New York
The purpose of this role is to:
Deliver strategic regulatory guidance for assigned projects/products with moderate level of supervision.
Ensures strategies are in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines.
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.
May act as direct liaison with Health Authorities or indirect liaison (in conjunction with Country Regulatory Leads (CRLs)) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures, with some level of guidance/supervision, as required.
Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.
Implement regulatory strategies in support of new submissions and to maintain registrations. Maintain product licenses across all product platforms.
Understand the 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:
Contribute to the development of Global/Regional regulatory strategies and implementation plans developed for assigned projects/products.
Partnering with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, PGS, etc.) to ensure required regulatory contributions (briefing documents, Global Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) achieve the objectives in the strategy, meet business needs while assuring compliance to applicable regulations 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.
Has responsibility for leading routine submissions and works across matrixed lines to track status and assure regulatory deliverables are met.
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.
Enables 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., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential
5+ years of experience in Relevant Global and/or Regional regulatory experience
Understanding of the regulatory environment and how this impacts regulatory strategy development and implementation
Experience (preferably within a Regulatory/Health Authority role) in supporting/ managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management
Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable
Proven ability to manage routine regulatory issues with the ability to contribute to complex issues. Proven ability to consistently deliver to time, cost and quality
Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical and other partner lines to achieve objectives.
Experience in successfully communicating with major Health Authority(ies), including 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.
Strong written and verbal communication skills. Ability to work well with appropriate level of independence and a moderate level of supervision
Reports to Upjohn Regulatory Strategy Team Lead
Partners with other Regulatory Strategists and Upjohn CMC team to assure consistent and appropriate regulatory support
Partners with other relevant Upjohn R,D & M and Innovative GRA /WRD colleagues and relevant project team(s) members from other partner lines (i.e. Safety, Commercial, Medical/Clinical, DSRD, Pharmaceutical Sciences, Legal, etc.).to achieve objectives
Works directly or indirectly with external contacts in Health Authorities within assigned portfolio, as well as with relevant experts and key opinion leaders
Additional Offer Details:
Last Date to Apply for Job: May 20, 2020
Additional Location Information: Open to Pfizer US sites, US- New York, New York; Peapack, New Jersey; Collegeville, Pennsylvania
Eligible for Employee Referral Bonus
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.