Associate 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.

ASSOCIATE DIRECTOR, CMC REGULATORY AFFAIRS

Summary

This individual’s primary responsibility will be to establish and execute global CMC regulatory strategies for commercial compounds in Ionis’ product pipeline. This is a team and individual contributor role, reporting to the Director, CMC Regulatory Affairs. This individual will collaborate and coordinate cross-functionally at Ionis, and with partner companies and vendors, to complete accurate and compliant regulatory documentation and ensure all regulatory requirements are met according to established timelines. The successful candidate will be able to: (1) understand and fulfill complex CMC requirements for global submissions, (2) work independently to manage projects and deliver output in a timely manner with limited supervision, (3) provide CMC regulatory leadership within Regulatory Affairs and on cross-functional teams, (4) serve as a liaison between regulatory authorities and the company regarding CMC issues to ensure timely approvals, (5) manage progress and completion of responsibilities to ensure delivery of CMC regulatory submissions in accordance with health authority deadlines, established departmental goals and objectives, and project plans and milestones, and (6) maintain current knowledge and expertise of relevant FDA, EMA, MHRA, JP, CN, and ICH guidelines and regulations.

WORK LOCATION: onsite/hybrid - Carlsbad, CA preferred; open to remote

Responsibilities

• Develop and execute global CMC regulatory strategies in collaboration with CMC RA colleagues and CMC subject matter experts in an environment committed to the efficient and aggressive development and commercialization of new drugs for patients
• Lead the preparation of complex CMC regulatory submissions for new drug applications in US, Canada, EU, UK, MENA, LATAM, and APAC regions by navigating and fulfilling regional regulatory requirements, customizing CTD sections, and collecting necessary ancillary documents
• Lead CMC regulatory aspects of partnered programs to ensure overall CMC strategy is achieved and to ensure delivery of required regulatory support and submissions
• Prepare, communicate, and drive timelines to ensure delivery of CMC regulatory submissions in accordance with health authority deadlines, established departmental goals and objectives, and project plans and milestones
• Facilitate timely regulatory approvals of new drug applications by ensuring the quality, accuracy, and completeness of submissions
• Understand and fulfill CMC post-approval regulatory activities for commercial products by assessing regulatory impact of manufacturing change controls, preparing post-approval changes/ variations, and performing lifecycle maintenance across global markets
• Participate in cross-functional teams to lead the timely preparation of high-quality regulatory submissions (including initial NDAs, post-approval changes/variations, query responses, and briefing documents)
• Support scientific advice / meetings with regulatory agencies to resolve CMC issues and ensure efficient drug development and drug approval
• Maintain knowledge of current and emerging regulatory legislation/guidance impacting CMC requirements

COMPETENCIES IDENTIFIED FOR SUCCESS

• Proven functional expertise with preparation and execution of CMC regulatory strategies and submissions for global markets
• Strong and effective communication (verbal and written), interpersonal, and teamwork skills
• Action-oriented, with ability to efficiently manage multiple priorities with aggressive timelines at a high level of productivity and proficiency
• Detail-oriented, with proficient regulatory writing skills
• Ability to work effectively and collaboratively towards a shared goal
• Ability to work independently to manage projects and deliver output in a timely manner with limited supervision

Requirements

• Bachelor’s Degree in a scientific discipline (e.g., chemistry, biological sciences, engineering) required; advanced degree preferred
• Minimum of 12 years of regulatory experience in the pharmaceutical industry
• Successful experience interacting with regulatory agencies
• Demonstrated ability to prepare and deliver complex CMC regulatory submissions for new drug applications and post-approval changes/variations in US, Canada, EU, UK, MENA, LATAM, and APAC regions
• Strong knowledge of eCTD elements and structure
• Strong knowledge of commercial lifecycle management requirements
• Proficiency in FDA, EU, ICH, USP, EP, JP, and other global requirements and guidelines related to regulatory submissions and cGMP operations
• Demonstrated ability to leverage artificial intelligence tools as an aid to support and enhance the execution of complex tasks, prepare presentations, and improve efficiency

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link:

The pay scale for this position is $181,162 to $224,717

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.