Director/Sr. Director Regulatory CMC, Lilly Gene Therapy
Scorpion Therapeutics, Indiana, Pennsylvania, us, 15705
Role Summary
Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for the gene therapy portfolio, shaping the regulatory path from early development through commercialization and ensuring compliance with global health authority requirements.
Responsibilities
Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions.
Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions, ensuring scientific accuracy, clarity, and adherence to regulatory guidelines.
Act as the primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) for assigned gene therapy projects, leading and facilitating interactions, teleconferences, and meetings.
Provide expert regulatory CMC guidance and support to cross-functional development teams (e.g., R&D, Manufacturing, Quality, Clinical) throughout the product lifecycle.
Proactively identify and assess regulatory CMC risks and opportunities, developing mitigation strategies and providing strategic recommendations to senior leadership.
Stay current with evolving global regulatory requirements, guidelines, and industry best practices pertaining to gene therapies and advanced therapeutic medicinal products (ATMPs).
Lead and mentor junior regulatory CMC professionals, encouraging a culture of excellence and continuous improvement.
Contribute to the development and improvement of internal regulatory CMC processes, standards, and templates.
Manage external consultants and contractors as needed to support regulatory CMC activities.
Qualifications
Required: Education — Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering); advanced degree (MS, Ph.D.) strongly preferred.
Required: Experience — 5+ years of regulatory CMC experience for gene therapy, cell therapy, or other ATMPs; 5+ years of global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA, etc.).
Preferred Qualifications
In-depth knowledge of global regulatory requirements and guidelines for biologics and ATMPs (e.g., ICH, FDA, EMA).
Strong scientific understanding of gene therapy technologies, manufacturing processes, and analytical methods.
Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely.
Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders.
Strategic thinker with strong problem-solving and decision-making abilities.
Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment.
Proficiency in regulatory information management systems and Microsoft Office Suite.
Education
Bachelor's degree in a scientific discipline; advanced degree (MS, Ph.D.) preferred.
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Responsibilities
Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions.
Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions, ensuring scientific accuracy, clarity, and adherence to regulatory guidelines.
Act as the primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) for assigned gene therapy projects, leading and facilitating interactions, teleconferences, and meetings.
Provide expert regulatory CMC guidance and support to cross-functional development teams (e.g., R&D, Manufacturing, Quality, Clinical) throughout the product lifecycle.
Proactively identify and assess regulatory CMC risks and opportunities, developing mitigation strategies and providing strategic recommendations to senior leadership.
Stay current with evolving global regulatory requirements, guidelines, and industry best practices pertaining to gene therapies and advanced therapeutic medicinal products (ATMPs).
Lead and mentor junior regulatory CMC professionals, encouraging a culture of excellence and continuous improvement.
Contribute to the development and improvement of internal regulatory CMC processes, standards, and templates.
Manage external consultants and contractors as needed to support regulatory CMC activities.
Qualifications
Required: Education — Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering); advanced degree (MS, Ph.D.) strongly preferred.
Required: Experience — 5+ years of regulatory CMC experience for gene therapy, cell therapy, or other ATMPs; 5+ years of global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA, etc.).
Preferred Qualifications
In-depth knowledge of global regulatory requirements and guidelines for biologics and ATMPs (e.g., ICH, FDA, EMA).
Strong scientific understanding of gene therapy technologies, manufacturing processes, and analytical methods.
Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely.
Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders.
Strategic thinker with strong problem-solving and decision-making abilities.
Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment.
Proficiency in regulatory information management systems and Microsoft Office Suite.
Education
Bachelor's degree in a scientific discipline; advanced degree (MS, Ph.D.) preferred.
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