Solomon Page
Dir/Sr. Dir. Regulatory Affairs
Solomon Page, Convent Station, New Jersey, us, 07961
The Senior Director of Regulatory Affairs provides strategic leadership and regulatory strategies for asset development and life cycle management of approved products.
ResponsibilitiesCreation of regulatory strategy and successful execution of activities, including submission preparation, oversight of all interactions and point of contact for communications with regulatory authoritiesOversees and interprets regulations, guidelines, procedures, and policies related to the development and global registration of drug products, with a specific focus on clinical development and global registrationLeads and advises on all regulatory related initiatives, providing expert guidance to clinical CROs, regulatory vendors, and area authors/reviewers on submission and dossier requirementsOversee departmental regulatory operations initiatives, timelines are met and aligned to the set strategyCreates and executes detailed regulatory submission project and resource plans, sets goals, and tracks progress towards critical milestones for major regulatory submissionsRequired Qualifications:
Bachelor's degree (or) Masters, life sciences or related discipline with a minimum of 10 years in pharmaceutical development within the US/Global
If you meet the required qualifications and are interested in this role, please apply today.
The Solomon Page Distinction
Our teams, comprised of subject matter experts, develop an interest in your preferences and goals and we act as an advisor for your career advancement. Solomon Page has an extensive network of established clients which allows us to present opportunities that are well-suited to your respective goals and needs - this specialized approach sets us apart in the industries we serve.
About Solomon Page
Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit: solomonpage.com and connect with us on Facebook , and LinkedIn .
Opportunity Awaits.
#regul atorystrategy
ResponsibilitiesCreation of regulatory strategy and successful execution of activities, including submission preparation, oversight of all interactions and point of contact for communications with regulatory authoritiesOversees and interprets regulations, guidelines, procedures, and policies related to the development and global registration of drug products, with a specific focus on clinical development and global registrationLeads and advises on all regulatory related initiatives, providing expert guidance to clinical CROs, regulatory vendors, and area authors/reviewers on submission and dossier requirementsOversee departmental regulatory operations initiatives, timelines are met and aligned to the set strategyCreates and executes detailed regulatory submission project and resource plans, sets goals, and tracks progress towards critical milestones for major regulatory submissionsRequired Qualifications:
Bachelor's degree (or) Masters, life sciences or related discipline with a minimum of 10 years in pharmaceutical development within the US/Global
If you meet the required qualifications and are interested in this role, please apply today.
The Solomon Page Distinction
Our teams, comprised of subject matter experts, develop an interest in your preferences and goals and we act as an advisor for your career advancement. Solomon Page has an extensive network of established clients which allows us to present opportunities that are well-suited to your respective goals and needs - this specialized approach sets us apart in the industries we serve.
About Solomon Page
Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit: solomonpage.com and connect with us on Facebook , and LinkedIn .
Opportunity Awaits.
#regul atorystrategy