Associate Director, Regulatory Affairs CMC
Scorpion Therapeutics, Cambridge, Massachusetts, us, 02140
Role Summary
Associate Director, Regulatory Affairs CMC, based in San Francisco, CA; responsible for developing and executing CMC regulatory strategies for Olema product(s) in development and post-approval, ensuring alignment with Health Authority requirements globally, and providing guidance for high quality and on-time CMC sections of regulatory submissions. Also provide CMC regulatory strategy support to cross-functional teams. This role is based out of our San Francisco, CA office and will require 10% travel. Responsibilities
Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs) Support regulatory agency interactions to ensure alignment on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements and variations Provide CMC support on the global regulatory plan, development plans/clinical study designs and risk assessments Proactive and effective communication of critical issues and potential mitigations with teams, senior management and key stakeholders in a timely manner Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines Manage and ensure compliance with all reporting requirements, including annual and periodic reports Collaborates well with internal and external teams (CMC, QA, Supply Chain, RA etc) Assist with the planning, compilation, review, approval and submission of high-quality CMC related sections of regulatory submissions, including responses to questions from various regulatory authorities, working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation Support interactions with regulatory agencies during inspections Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs Qualifications
Required: Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus Required: Excellent knowledge of current CMC regulations and regulatory procedures Required: Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP Required: Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases early to late-stage Required: Minimum 8 years of experience in clinical research, biotech, and/or pharmaceutical company, with minimum 6 years of Regulatory Affairs experience within clinical research or pharmaceutical Required: Experience in small molecule drug development; oncology experience a plus Required: Global CMC regulatory experience for clinical trials Preferred: Post-approval (commercial) experience Required: Experience with eCTD requirements and electronic submissions Preferred: Experience with international regulatory submissions and processes Required: Strong business acumen and ability to work with international and cross-functional partners Required: Very strong strategic skills with ability to balance short-term needs and long-term vision Required: Proven ability to deliver on goals within a cross-functional team environment with professionalism Required: Excellent verbal, written and presentation skills Required: Ability to analyze and convey difficult and complex issues clearly to internal and external stakeholders Required: Foster open communication, listen and facilitate discussion Required: Maintain learner mindset and adapt to changing environment Required: Ability to prioritize and manage multiple tasks efficiently Skills
Communication and collaboration across cross-functional teams Strategic thinking and problem solving in regulatory contexts Regulatory intelligence and risk assessment Regulatory submissions planning and management Quality systems knowledge related to regulatory processes Education
Bachelor's degree in a scientific field required; advanced degree a plus
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Associate Director, Regulatory Affairs CMC, based in San Francisco, CA; responsible for developing and executing CMC regulatory strategies for Olema product(s) in development and post-approval, ensuring alignment with Health Authority requirements globally, and providing guidance for high quality and on-time CMC sections of regulatory submissions. Also provide CMC regulatory strategy support to cross-functional teams. This role is based out of our San Francisco, CA office and will require 10% travel. Responsibilities
Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs) Support regulatory agency interactions to ensure alignment on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements and variations Provide CMC support on the global regulatory plan, development plans/clinical study designs and risk assessments Proactive and effective communication of critical issues and potential mitigations with teams, senior management and key stakeholders in a timely manner Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines Manage and ensure compliance with all reporting requirements, including annual and periodic reports Collaborates well with internal and external teams (CMC, QA, Supply Chain, RA etc) Assist with the planning, compilation, review, approval and submission of high-quality CMC related sections of regulatory submissions, including responses to questions from various regulatory authorities, working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation Support interactions with regulatory agencies during inspections Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs Qualifications
Required: Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus Required: Excellent knowledge of current CMC regulations and regulatory procedures Required: Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP Required: Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases early to late-stage Required: Minimum 8 years of experience in clinical research, biotech, and/or pharmaceutical company, with minimum 6 years of Regulatory Affairs experience within clinical research or pharmaceutical Required: Experience in small molecule drug development; oncology experience a plus Required: Global CMC regulatory experience for clinical trials Preferred: Post-approval (commercial) experience Required: Experience with eCTD requirements and electronic submissions Preferred: Experience with international regulatory submissions and processes Required: Strong business acumen and ability to work with international and cross-functional partners Required: Very strong strategic skills with ability to balance short-term needs and long-term vision Required: Proven ability to deliver on goals within a cross-functional team environment with professionalism Required: Excellent verbal, written and presentation skills Required: Ability to analyze and convey difficult and complex issues clearly to internal and external stakeholders Required: Foster open communication, listen and facilitate discussion Required: Maintain learner mindset and adapt to changing environment Required: Ability to prioritize and manage multiple tasks efficiently Skills
Communication and collaboration across cross-functional teams Strategic thinking and problem solving in regulatory contexts Regulatory intelligence and risk assessment Regulatory submissions planning and management Quality systems knowledge related to regulatory processes Education
Bachelor's degree in a scientific field required; advanced degree a plus
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