Principal Regulatory Affairs Specialist

KMR Search Group · Удалённо · United States

# Principal Regulatory Affairs Specialist **KMR Search Group** · United States · `Remote` · `Full Time` 💼 **Уровень роли:** `Senior` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Regulatory-Affairs-Specialist]` `[Regulatory-Affairs-Manager]` `[Regulatory-Affairs]` `[Regulatory-Compliance-Specialist]` `[Principal-Regulatory-Affairs-Specialist]` `[Regulatory-Affairs-Principal]` `[Principal-Regulatory-Affairs]` `[Principal-Regulatory-Affairs-Consultant]` `[Senior-Regulatory-Affairs]` `[Senior-Regulatory-Affairs-Associate]` --- ### About the Role The Principal Regulatory Affairs (RA) Specialist, will manage and lead regulatory submissions and develop regulatory strategies for investigational and marketed products by interacting effectively within a cross-functional project team of internal and external subject matter experts. The scope of regulatory submissions will focus on CMC and will also include clinical and non-clinical submission. This position serves as the regulatory representative on relevant project teams and as the regulatory contact with health authorities. - Actively understand and interpret industry trends and health authority's expectations in areas related to CMC, non-clinical and clinical. Influence and communicate how these trends align with strategic department direction and vision. - Develop regulatory strategy for CMC, non-clinical, and clinical and define the corresponding submission deliverables for assigned development projects or programs and for post- approval changes and ensure implementation of agreed upon strategies. - Provide technical and strategic direction on CMC, non-clinical and clinical issues throughout product development and commercialization. - Monitor changes to development plans and provide regulatory guidance to teams - Represent Regulatory Affairs at various project team and working group meetings. - Act as a direct point of contact with FDA and participate in meetings for CMC, non-clinical and clinical issues. - Collaborate with equivalent cross-functional colleagues concerning CMC, non-clinical and clinical interests to meet project milestones. - Lead in regulatory due diligence activities as assigned. - Act as a direct point of contact with FDA and participate in meetings for CMC, non-clinical and clinical related issues. - Execute strategies to ensure rapid and timely approval of applications for new and marketed products. - Maintain cross-functional awareness of and expertise in ICH, FDA and EU guidelines related to regulatory topics. - Liaison with business partners on regulatory matters on assigned programs - Collaborate with RA senior management to create and implement policies, processes, and procedures supporting the department goals and objectives. Requirements: A minimum of a Bachelor's degree in related science field and 9+ years of experience is required. An advanced degree is preferred (minimum 7+ years with MS, minimum 4+ years with PhD). Must have regulatory experience in the pharmaceutical industry, with experience in a multi-project environment. The candidate must have proven ability to lead and work effectively in cross-functional teams. Minimum of 3+ years of demonstrated leadership skills. Other Knowledge, Skills, and Abilities: - 505 b2 and generic experience along with managerial experience is preferred. - Experience with international health authorities is preferred. - Extensive knowledge of US CMC regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues. - Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, regulations and guidelines. - Comprehensive knowledge and experience in CMC sections for investigational and marketed product submissions for FDA. Must have strong strategic and critical thinking, leadership, diplomacy and negotiation skills. - Excellent written and verbal communications skills. - Must be able to effectively communicate with scientists at all levels. - Demonstrated ability to work in and lead effectively in matrix teams. - Strong organization and time management skills. - Demonstrated ability to influence based on experience, facts and data. Originally posted on Himalayas

Наблюдалась 2026-10-10, впервые 2026-10-10, источник — Himalayas (JSON API).

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