This listing was posted on Manatal ATS.
Regulatory Strategy Senior Manager
Location:
London, Gt Lon
Description:
The Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for development and/or commercial product(s) within the Vertex portfolio. This role requires understanding of regulatory affairs frameworks in Europe, and/ or International/ RoW markets and understanding of drug development, CMC and supply chain regulations. Key Responsibilities: Leads the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team Contributes to and may lead global regulatory strategy development for certain programs Responsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authority Provides guidance to teams on regulatory requirements for development and approval pathways for assigned region, including potential for expedited pathways Manages the process for preparation, submission, and approval of regulatory applications within assigned region Provides strategic and technical regulatory input for key product development or registration documents Ensures compliance of regulatory submissions with current regulations and guidance Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy in assigned region. Key Requirements: Relevant educational degree Knowledge of relevant regulatory frameworks Good understanding of drug development and related concepts Good understanding of requirements and processes to maintain a product on the market; reporting and surveillance Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment Strong problem-solving skills Strong written and verbal communication skills to explain difficult information and build alignment Ability to work effectively within a team environment Ability to plan, prioritize, and execute work and projects in a systematic and efficient manner. Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Please use the below Lifelancer link for job application and quicker response. https://lifelancer.com/jobs/view/83e9012857268604b05b95b1d3fee24f
Company:
Lifelancer
Posted:
July 25 on Manatal ATS
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