Senior Manager, Regulatory Strategy
4 days ago
Job DescriptionGeneral Summary: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 the US, Europe, or other international markets, and understanding of drug development and related concepts.Key Duties and Responsibilities:Leads the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional teamContributes to and may lead global regulatory strategy development for certain programsResponsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authorityProvides guidance to teams on regulatory requirements for development and approval pathways for assigned region, including potential for expedited pathwaysManages the process for preparation, submission, and approval of regulatory applications within assigned regionProvides strategic and technical regulatory input for key product development or registration documentsEnsures compliance of regulatory submissions with current regulations and guidanceReviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy in assigned regionKnowledge and Skills:In-depth knowledge of global and regional regulatory affairs frameworksGood understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacologyGood understanding of requirements and processes to maintain a product on the market; reporting and surveillanceAbility to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessmentStrong problem-solving skillsStrong written and verbal communication skills to explain difficult information and build alignmentAbility to work effectively within a team environmentAbility to plan, prioritize, and execute work and projects in a systematic and efficient mannerEducation and Experience:Bachelor's degree in Biology, Chemistry, or other related disciplineTypically requires 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experienceWe’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:1. Hybrid and work remotely up to two days per week; or select2. On-Site and work 5 days per week with ad hoc flexibility.
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Senior Director, Regulatory Strategy
6 days ago
Boston, United States Vertex Full timeJob DescriptionGeneral Summary:The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in...
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Boston, MA, United States Olema Oncology Full timeOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product...
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Boston, MA, United States Olema Oncology Full timeOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product...
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Boston, MA, United States Olema Oncology Full timeOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product...
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Boston, MA, United States Olema Oncology Full timeOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product...
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Senior Director, Regulatory Strategy Consulting
2 weeks ago
Boston, United States Halloran Consulting Group, Inc. Full timeSenior Director, Regulatory Strategy ConsultingJoin Halloran Consulting Group, Inc. as a Senior Director, Regulatory Strategy Consulting. Reporting to the Vice President of Regulatory Affairs, this leader will shape and drive global regulatory strategies across diverse therapeutic portfolios. You will combine deep regulatory expertise, strategic foresight,...
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Senior Director, Regulatory Strategy Consulting
3 weeks ago
Boston, United States Halloran Consulting Group Full timeSenior Director, Regulatory Strategy Consulting Join Halloran Consulting Group, Inc. as a Senior Director, Regulatory Strategy Consulting. Reporting to the Vice President of Regulatory Affairs, this leader will shape and drive global regulatory strategies across diverse therapeutic portfolios. You will combine deep regulatory expertise, strategic foresight,...
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Boston, United States Halloran Consulting Group, Inc. Full timeSenior Director, Regulatory Strategy Consulting Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran’s Regulatory team as a Senior Director, Regulatory Strategy Consulting today! Reporting to the Vice President of Regulatory Affairs, this leader will...
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Boston, United States Takeda Pharmaceutical Company Ltd Full timeBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
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Boston, United States Boston Staffing Full timeSenior Manager, Global Regulatory Labeling StrategyAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies...
