Associate Director, Regulatory Affairs, CMC

🕒 6 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $132.000 - $198.000 / ano

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GE HealthCare

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1892

💊 Farmacêutico

Healthcare • Medical Technology • Pharmaceuticals

A GE HealthCare é líder em cuidado de precisão, dedicada a oferecer tecnologias inovadoras e soluções integradas que elevam a qualidade dos serviços de saúde. Como empresa independente, tem foco em diagnóstico por imagem, ultrassom e TI em saúde, capacitando profissionais de saúde e melhorando os desfechos dos pacientes por meio de tecnologias médicas avançadas e soluções de cuidado personalizado. Com investimento significativo em pesquisa e desenvolvimento (P&D), a GE HealthCare busca transformar a área da saúde, tornando os hospitais mais eficientes e as terapias mais precisas.

Descrição

• To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products. • Build, or provide input to, submission strategy documents by defining supplement type, data required to support submission, and submission documents required for the submission package. • Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted. • Author and review individual CMC submission documents/CMC dossier sections to support regulatory submissions. • Provide consistent expert advice to the organization, determining feasible regulatory strategies and identify potential options, to assist in delivering optimal business value or mitigate compliance issues. • Maintain registration tracking information and assist in the development of good document management practice standards. • Work closely with global RA and, regional RA’s to address questions from regulatory authorities.

🎯 Requisitos

• Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or related discipline (Doctor of Pharmacy (PharmD) or MSc in radiopharmacy preferred). • Minimum 3 years of experience in Regulatory Affairs or Quality, with a track record of supporting marketed products and/or clinical development of radiopharmaceuticals. • Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds. • Experience with regulatory submissions for post-approval changes, including FDA supplements and EU variations. • Ability to prioritize, plan & evaluate deliverables to established strategic goals for complex projects, including scientific discussions on how best to present information. • Strong problem solving and negotiation skills. • Demonstrated experience of operating in a highly regulated environment. • Capable of applying analytical skills in a CMC regulatory environment. • Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines. • Has the capability to influence managers and help drive decisions at a project level. • Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences. • Demonstrated strong ability in written and oral English in order to clearly and concisely present information targeted to the relevant audience. • Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products. • Ability to interpret global regulations and present to the wider business. • Experience in electronic document management and Quality management systems. • Ability to proactively champion projects & experienced in mentoring team members. • Knowledge of international CMC regulatory requirements. • Strong interpersonal skills and ability to engage effectively with colleagues at all levels. • Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters). • Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry . • Experience of regulatory project management and regulatory agency interactions. • Experience with Veeva RIM or other registration tracking tools. • Ability to work across cultures/countries/sites. • Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

🏖️ Benefícios

• medical • dental • vision • paid time off • a 401(k) plan with employee and company contribution opportunities • life • disability • accident insurance • tuition reimbursement