Joseph Fisher Email and Phone Number
Senior Regulatory Affairs Consultant and Advisor at
@
Flourish Regulatory and Quality Consultants LLC
California, United States
Joseph Fisher's Location
Redwood City, California, United States, United States
About Joseph Fisher
Accomplished regulatory affairs leader with over 15 years of experience in global pharmaceutical regulatory affairs. Experienced in leading and providing strategic regulatory guidance for international drug development programs across various therapeutic areas. Proficient in all stages of drug development, clinical trials, registration, and the life cycle of marketed products in different dosage forms. Successfully developed and maintained regulatory strategies, conducted risk assessments, and established contingency plans for global development plans. Skilled in effectively communicating with regulatory agencies worldwide, organizing and chairing successful meetings with international health authorities. Highly experienced in leading cross-functional teams to prepare and submit regulatory submissions to global health authorities. Also played a significant role in recruitment, establishing company standard operating procedures, and providing staff support and training. Consistently assessed the impact of regulations and guidance on program plans, ensuring compliance and readiness for regulatory changes or challenges. Possess strong business acumen, excellent communication skills, and the ability to build trust and respect within organizations.
Joseph Fisher's Current Company Details
Flourish Regulatory And Quality Consultants Llc
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Senior Regulatory Affairs Consultant and Advisor
California, United States
Joseph Fisher Work Experience Details
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Senior Regulatory Affairs Consultant And AdvisorFlourish Regulatory And Quality Consultants LlcCalifornia, United States
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Senior Regulatory Affairs Consultant And AdvisorJoseph Fisher Self Employed Mar 2020 - Present-Provide regulatory and operational support for all stages of drug product development. This includes strategy development, risk management, contingency planning, and project tracking.-Draft target product profiles, labeling, and eligibility for expedited review programs.-Provide guidance and support for global regulatory submissions, regulatory agency communications, and meetings. Track commitments and maintain applications to meet strategic business goals.-Develop standard operating procedures, work instructions, and training programs.-Conduct regulatory assessments and competitive surveillance. Ensure all regulatory requirements are met for product launches and manage multidisciplinary teams.-Developed an AI tool for compiling global regulatory submissions and international health authority regulations, assessing country clinical trial feasibility, and improving operational efficiency by at least 50%. I have also submitted and managed dozens of INDs, CTAs, NDAs, and MAAs.
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Head Of Regulatory Affairs (Cro)Vial Dec 2022 - Feb 2024-Provided leadership in regulatory affairs and managed all regulatory activities.-Contributed to the development of a proprietary regulatory intelligence database.-Supported company expansion by creating and executing strategies for drug development programs and ensured effective regulatory planning and risk management.-Involved in creating clinical development plans in line with regulatory policies and guidelines. -
Executive Director, Regulatory AffairsStar Therapeutics Nov 2022 - Mar 2023South San Francisco, California, Us-Led global regulatory activities for VEGA-VGA039, a treatment for von Willebrand Disease, a bleeding disorder, including developing global regulatory strategies and registration pathways. -Developed and executed regulatory submission strategies and engaged with international health authorities regarding drug development plans.-Involved in developing company policies and procedures and delivering training programs to ensure compliance with global regulatory requirements. -
Senior Director, Clinical Regulatory AffairsMyovant Sciences May 2021 - Mar 2022Brisbane, Ca, UsAcquired by Sumitovant Biopharma-Led the global regulatory development program for Myfembree, involving interactions with the FDA and international agencies.-Responsible for maintaining IND and NDA submissions, collaborating with cross-functional teams on regulatory strategies and documents for regulatory submissions, and leading communications with health authorities.-Developed and delivered training programs for global regulatory requirements, ensuring the company was prepared to enter diverse international markets.-Created regulatory plans aligned with corporate timelines, optimizing resources and reducing submission times by an average of 1 month.-Provided training that improved team knowledge and increased productivity by at least 30%. -
Layoff/Position EliminatedCareer Break Mar 2020 - Mar 2022Out of Work Due to the COVID-19 Pandemic, Per Diem Contracts
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Senior Director, Head Of Regulatory Affairs (Oncology, Adcs)Sutro Biopharma, Inc. Apr 2019 - Mar 2020South San Francisco, California, Us-Provided global strategic leadership for regulatory objectives, including INDs, DMFs, and international filings for antibody-drug conjugates (ADCs) under development.-Offered strategic guidance to project teams, cross-functional partners, and external collaborators to develop and execute global plans.-Served as the primary point of contact for communications with the FDA, EMA, and other international health authorities-Provided expert guidance on the regulatory landscape to influence product development and lifecycle management.-Developed regulatory, departmental, and company policies, created standard operating procedures, and managed regulatory staff. -
Independent Senior Regulatory Affairs Consultant And AdvisorRegulatory Consultant Sep 2018 - Mar 2019-Developed and implemented international regulatory strategies, evaluated the likelihood of success, established project objectives, conducted risk assessments, prepared contingency plans, led international regulatory teams, and coordinated contributions for regulatory submissions and meetings worldwide.
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Director Of Regulatory AffairsAdverum Biotechnologies, Inc. Sep 2017 - Aug 2018Redwood City, California, Us-Responsible for developing and implementing regulatory strategies, submitting regulatory documentation, leading international health authority interactions, and managing regulatory responsibilities for ADVM-022 (Ixovec), a gene therapy product candidate for treating wet AMD.-Submitted an IND (OPTIC) and fast-track designation application and provided expert guidance on regulatory matters to influence product development.-Strategized and successfully executed a plan to obtain fast-track designation, resulting in savings, investments, and grant opportunities for the company. -
Senior Regulatory ConsultantPharmalex Jan 2015 - Aug 2017Bad Homburg, De-Responsible for developing and implementing regulatory strategies for Investigational New Drug applications (INDs) for Anetumab Ravtansine, an antibody-drug conjugate being investigated for treating mesothelioma.-Ensured timely submission and approval of global development projects, evaluated the likelihood of regulatory success, set project goals, and led the global regulatory affairs team.-Introduced an automated system for tracking regulatory health authority commitments and company responses, which increased compliance response rates by at least 30%.-Played a vital role in a cross-departmental task force that addressed compliance issues, significantly reducing potential regulatory infractions.-Conducted due diligence assessments for acquisitions, identifying opportunities and regulatory risks influencing business decisions. -
Global Established Products Regulatory Affairs, Partner ManagementPfizer Jul 2012 - Nov 2014New York, New York, Us-Coordinated with regional leads to develop portfolio strategies and provide input for global regulatory plans for Pfizer's global generics portfolio, which comprises more than 50 products.-Responsible for managing regulatory strategies and milestones and collaborated with commercial and platform functions to ensure compliance with regulations and business goals; identified region-specific risks, developed mitigation plans, evaluated rules for their impact on the registered portfolio, and managed registration lifecycles. This also included enhancing or reducing the portfolio to meet commercial targets.-Conducted detailed analysis and reporting of post-marketing surveillance data to improve patient safety and ensure compliance with post-marketing commitments.-Fostered a culture of improvement by conducting process audits, resulting in a 60% increase in overall efficiency. -
Co-FounderNesting Egg Home Care Jan 2011 - Jul 2012Mercer County, New Jersey, Us-Managed a home care provider agency, overseeing operational activities, customer service, recruitment, staffing, and sales. Also, set company objectives and supervised staff to ensure compliance with regulations. -
Senior Manager Regulatory AffairsCelgene May 2009 - Jan 2011Summit, New Jersey, Us-Developed and implemented regulatory plans for Thalomid and Revlimid, including submitting a supplemental new drug application and an orphan drug designation application. Additionally, submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Revlimid with dexamethasone for MDS with 5Q deletion. Managed global and regional regulatory teams, developed and executed regulatory strategies, liaised with regulatory agencies, planned pathways for orphan drug designation, stayed updated on regulations, and led submission and meeting preparations while representing regulatory affairs on the cross-functional project team. -
Manager, Global Regulatory AffairsJohnson & Johnson Feb 2007 - May 2009New Brunswick, Nj, Us-Responsible for managing regulatory activities for female contraceptives and the CNS/pain portfolios. This involved developing the DURAGESIC Matrix and obtaining pediatric indication and exclusivity for AXERT. Oversaw more than 30 oral analgesic drug products, including orals, patches, and prefilled syringe combinations. Developed strategic regulatory plans, led cross-functional teams, and ensured compliance with health authority requirements. Developed regulatory plans, led cross-functional teams, and ensured compliance with health authority requirements. -
Regulatory Affairs ManagerAstrazeneca Mar 2004 - Feb 2007Cambridge, Cambridgeshire, Gb-Developed and executed regulatory strategies for products in the gastrointestinal (GI) and cardiovascular (CV) therapeutic areas. Advised cross-functional teams, prepared submissions, facilitated interactions with health authorities, and worked closely with drug safety for regulatory reporting. Conducted research on updated regulations and competitor activities, served as the primary regulatory representative in multidisciplinary project teams, and led the training of junior staff, boosting team knowledge and productivity by at least 25%.
Joseph Fisher Education Details
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Adelphi UniversityBachelor'S Of Science -
Long Island UniversityMedical Biology- Immunology
Frequently Asked Questions about Joseph Fisher
What company does Joseph Fisher work for?
Joseph Fisher works for Flourish Regulatory And Quality Consultants Llc
What is Joseph Fisher's role at the current company?
Joseph Fisher's current role is Senior Regulatory Affairs Consultant and Advisor.
What schools did Joseph Fisher attend?
Joseph Fisher attended Adelphi University, Long Island University.
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