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Senior Manager, Regulatory Affairs Strategy


Columbia, MD
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Job Details

Job Title Senior Manager, Regulatory Affairs Strategy

JobID 1034644-1852

Location: Columbia, MD

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

Reports to Meridian Director, Regulatory Strategy (Cluster Lead)Works with internal WSR groups with the Meridian Medical Team in Columbia and relevant project teams. In addition works with relevant development/commercial team representatives within the PGS, and R&D (Worldwide Safety Operations and Risk Management, Worldwide Safety Sciences, Medical, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).The purpose of this position is to:*Generate regulatory strategies that align with the unique business needs of the Meridian Portfolio*Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.*Lead teams in FDA meetings related to the development of products in the Meridian Portfolio *Lead and/or participates in Regulatory Teams for assigned projects/products. *Understand regulatory environment and communicates priorities to global stakeholders*Deliver project strategy, risks, label and PRS


The major duties and responsibilities will include but are not limited to: *Accountable for ensuring or contributing to Global 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., Brand Teams) to ensure required regulatory contributions (line plans, IND, NDA) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.*Works closely with other Regulatory Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning 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 Associations as appropriate.*Ensures business compliance and implementation of and adherence to Regulatory standards.*Develops and maintains constructive working relationship with US Government contacts.*Develops and maintains constructive working relationship with Health Authority contacts.


Qualifications (i.e., preferred education, experience, attributes):*Scientific Degree. A higher degree may be an advantage but is not essential.*8 years of relevant experience with 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.*Regulatory experience including knowledge of NDA/IND, 505(b) (2) submission processes; drug-device experience and prior experience working with CDRH will be an advantage.Technical skills requirements: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 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 trainingCommercial Awareness - Demonstrated knowledge of global regulatory procedures and requirements. Understanding of regulatory agency philosophy and guidelines. Problem Solving and Analysis - Strong problem identification and solving skills, e.g. risk management planning. Strong logical and analytical skillsCommunication 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

*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. This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.

*Senior Manager, Regulatory Affairs Strategy*
*Columbia, Maryland*

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