Director, CMC Regulatory Affairs
Location
Carlsbad, CA | United States
Job description
Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.
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.
The successful candidate will be able to: (1) serve as a liaison between regulatory authorities and the company regarding CMC issues, (2) provide CMC regulatory leadership within Regulatory Affairs and on cross-functional teams, (3) Lead CMC regulatory aspects of wholly-owned and partnered programs for Ionis to ensure overall CMC strategy is achieved, (4) maintain current knowledge and expertise of relevant FDA, EMA, JP, and ICH guidelines and regulations, and (5) ensure progress and completion of responsibilities in accordance with established departmental goals and objectives or project plans and milestones.
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
- Minimum of 8 to 10 years of regulatory experience in the pharmaceutical industry; minimum of 3 years of experience in CMC regulatory affairs; 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 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
Please visit our website, for more information about Ionis and to apply for this position; reference requisition # IONIS003243
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis Benefits Full Benefits Link: The pay scale for this position is $185,846 to $268,585
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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