Ionis Brand
Associate Director/ Director, CMC Regulatory Affiars
Ionis Brand, Carlsbad, California, United States, 92011
Associate Director/Director, CMC Regulatory Affairs
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! Associate Director/Director, CMC Regulatory Affairs Summary: This individual's primary responsibility will be to help establish and execute the CMC regulatory strategy for clinical and commercial compounds in Ionis' product pipeline. This is a team and individual contributor role, reporting to the Executive Director, CMC Regulatory Affairs. This individual will collaborate and coordinate cross-functionally at Ionis, and with partner companies/vendors, to complete accurate and compliant regulatory documentation, and will interact with regulatory agencies to ensure timely NDA, MAA, NDS, and other global market authorization approvals, as well as CTA, IMPD, and IND approvals. Responsibilities: Serve as a liaison between regulatory authorities and the company regarding CMC issues Provide CMC strategy and direction regarding requirements for global regulatory submissions, from preclinical through commercial, in an environment committed to the efficient and aggressive development and commercialization of new drugs for patients Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality, accuracy, and completeness of submissions. Participate in cross-functional teams to support the timely preparation of high-quality regulatory submissions; provide specific focus on CMC sections of IND, CTA, IMPD, and commercial (NDA, MAA, NDS, JNDA etc.) filings and their amendments or supplements Lead scientific advice / meetings with regulatory agencies to ensure efficient drug development and drug approval Maintain knowledge of current and emerging regulatory legislation/guidance (e.g. EU MDR, CTR); support impact assessments and confirm compliance of Ionis' programs Lead CMC regulatory aspects of partnered programs to ensure overall CMC strategy is achieved and to ensure delivery of required regulatory support and submissions Provide regulatory oversight of new and revised material specifications and SOPSs that have regulatory impact Evaluate relevant facility, manufacturing, and analytical change controls to assess the regulatory impact and support their implementation, as needed Provide regulatory oversight for Ionis' Risk Management program and participate in risk assessment and mitigation activities Requirements: Bachelor's Degree in a scientific discipline (e.g., chemistry, biological sciences, engineering, etc.) required; advanced degree preferred At least 12 years of regulatory experience in the pharmaceutical industry; successful past experience interacting with regulatory agencies is a must. Experience related to development of clinical candidates and/or cGMP manufacturing processes is essential Strong knowledge of eCTD elements and structure, proficient regulatory writing skills, and experience related to early and late-stage clinical CMC regulatory submissions is essential; knowledge of commercial lifecycle management CMC regulatory submissions is a plus This individual will have and maintain proficiency in FDA, EU, ICH, USP, EP, JP, and other global requirements and guidelines related to regulatory submissions and cGMP operations Strong effective communication (verbal and written), interpersonal, and teamwork skills Ability to manage multiple priorities with aggressive timelines at a high level of productivity and proficiency Productive and successful in a dynamic work environment Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! Associate Director/Director, CMC Regulatory Affairs Summary: This individual's primary responsibility will be to help establish and execute the CMC regulatory strategy for clinical and commercial compounds in Ionis' product pipeline. This is a team and individual contributor role, reporting to the Executive Director, CMC Regulatory Affairs. This individual will collaborate and coordinate cross-functionally at Ionis, and with partner companies/vendors, to complete accurate and compliant regulatory documentation, and will interact with regulatory agencies to ensure timely NDA, MAA, NDS, and other global market authorization approvals, as well as CTA, IMPD, and IND approvals. Responsibilities: Serve as a liaison between regulatory authorities and the company regarding CMC issues Provide CMC strategy and direction regarding requirements for global regulatory submissions, from preclinical through commercial, in an environment committed to the efficient and aggressive development and commercialization of new drugs for patients Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality, accuracy, and completeness of submissions. Participate in cross-functional teams to support the timely preparation of high-quality regulatory submissions; provide specific focus on CMC sections of IND, CTA, IMPD, and commercial (NDA, MAA, NDS, JNDA etc.) filings and their amendments or supplements Lead scientific advice / meetings with regulatory agencies to ensure efficient drug development and drug approval Maintain knowledge of current and emerging regulatory legislation/guidance (e.g. EU MDR, CTR); support impact assessments and confirm compliance of Ionis' programs Lead CMC regulatory aspects of partnered programs to ensure overall CMC strategy is achieved and to ensure delivery of required regulatory support and submissions Provide regulatory oversight of new and revised material specifications and SOPSs that have regulatory impact Evaluate relevant facility, manufacturing, and analytical change controls to assess the regulatory impact and support their implementation, as needed Provide regulatory oversight for Ionis' Risk Management program and participate in risk assessment and mitigation activities Requirements: Bachelor's Degree in a scientific discipline (e.g., chemistry, biological sciences, engineering, etc.) required; advanced degree preferred At least 12 years of regulatory experience in the pharmaceutical industry; successful past experience interacting with regulatory agencies is a must. Experience related to development of clinical candidates and/or cGMP manufacturing processes is essential Strong knowledge of eCTD elements and structure, proficient regulatory writing skills, and experience related to early and late-stage clinical CMC regulatory submissions is essential; knowledge of commercial lifecycle management CMC regulatory submissions is a plus This individual will have and maintain proficiency in FDA, EU, ICH, USP, EP, JP, and other global requirements and guidelines related to regulatory submissions and cGMP operations Strong effective communication (verbal and written), interpersonal, and teamwork skills Ability to manage multiple priorities with aggressive timelines at a high level of productivity and proficiency Productive and successful in a dynamic work environment Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.