Proclinical Staffing
Senior Director, Clinical Regulatory Strategy
Proclinical Staffing, Trenton, New Jersey, United States
Overview
Senior Director, Clinical Regulatory Strategy – Permanent – New Jersey. Proclinical is seeking a Senior Director, Clinical Regulatory Strategy for a growing biopharmaceutical company based in New Jersey. Primary Responsibilities: In this role, you will direct, manage, evaluate and implement regulatory projects in support of company goals in the area of clinical strategy. The position will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting program/platform strategy. The position is based in New Jersey in a hybrid work schedule. Skills & Requirements: Bachelor's degree in an analytical field of study required, MBA desirable Minimum 10 years of relevant experience in Regulatory Affairs of pharmaceutical, biological, and/or medical device products required Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for change/refinements based on ongoing regulatory outcomes throughout development The Senior Director, Clinical Regulatory Strategy will: Lead the development of regulatory strategy for multiple and/or complex projects (from first-in-human to post-marketing application stage) outlined in Global Regulatory Strategy Documents, including for regulatory submissions documents and HA communications. Analyze and address complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and regulatory leadership. Advise senior management on status of global regulatory affairs strategies and tactics, practice, and procedures. Align with cross-functional teams to lead the development and management of project plans and timelines, followed by effective execution of the plan by ensuring all projects are appropriately prioritized and key goals are met on time. Influence regulatory environment by active participation in relevant conferences, trade associations, industry/agency regulatory meetings, committees; remain up-to-date on changing regulatory environment and provide regulatory policy and intelligence including competitive issues that influence regulatory strategy. Supervise and mentor direct reports to facilitate professional growth; identify training opportunities and provide mentoring to ensure individuals are appropriately developed in accordance with their roles and responsibilities. If you are having difficulty in applying or if you have any questions, please contact
Phu Huynh
at
(+1) 646-779-7961
or
p.huynh@proclinical.com . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
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Senior Director, Clinical Regulatory Strategy – Permanent – New Jersey. Proclinical is seeking a Senior Director, Clinical Regulatory Strategy for a growing biopharmaceutical company based in New Jersey. Primary Responsibilities: In this role, you will direct, manage, evaluate and implement regulatory projects in support of company goals in the area of clinical strategy. The position will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting program/platform strategy. The position is based in New Jersey in a hybrid work schedule. Skills & Requirements: Bachelor's degree in an analytical field of study required, MBA desirable Minimum 10 years of relevant experience in Regulatory Affairs of pharmaceutical, biological, and/or medical device products required Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for change/refinements based on ongoing regulatory outcomes throughout development The Senior Director, Clinical Regulatory Strategy will: Lead the development of regulatory strategy for multiple and/or complex projects (from first-in-human to post-marketing application stage) outlined in Global Regulatory Strategy Documents, including for regulatory submissions documents and HA communications. Analyze and address complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and regulatory leadership. Advise senior management on status of global regulatory affairs strategies and tactics, practice, and procedures. Align with cross-functional teams to lead the development and management of project plans and timelines, followed by effective execution of the plan by ensuring all projects are appropriately prioritized and key goals are met on time. Influence regulatory environment by active participation in relevant conferences, trade associations, industry/agency regulatory meetings, committees; remain up-to-date on changing regulatory environment and provide regulatory policy and intelligence including competitive issues that influence regulatory strategy. Supervise and mentor direct reports to facilitate professional growth; identify training opportunities and provide mentoring to ensure individuals are appropriately developed in accordance with their roles and responsibilities. If you are having difficulty in applying or if you have any questions, please contact
Phu Huynh
at
(+1) 646-779-7961
or
p.huynh@proclinical.com . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
#J-18808-Ljbffr