Global CMC Regulatory Lead for Submissions

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); Híbrido; USD 181.000 - 225.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Excellent benefits

Descripción de la vacante

Ionis Pharmaceuticals, Inc. seeks an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds in its pipeline.

You will collaborate with CMC RA colleagues, partner companies and vendors to ensure timely, accurate regulatory documentation and approvals. You will lead complex regulatory submissions across multiple regions, manage post-approval changes, and interact with regulatory authorities to support efficient drug

Formación

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Minimum 12 years regulatory experience in pharma.
• Proven experience with global CMC submissions (US, EU, UK, others).
• Strong knowledge of FDA, EMA, ICH guidelines and cGMP operations.

Responsabilidades

• Develop and execute global CMC regulatory strategies with cross-functional teams.
• Lead preparation of complex CMC regulatory submissions for global markets.
• Lead CMC regulatory aspects of partnered programs to ensure strategy alignment.
• Drive timelines to deliver regulatory submissions within deadlines.
• Support regulatory meetings with agencies to resolve CMC issues.
• Maintain knowledge of current regulatory guidelines and requirements.
• Collaborate to ensure quality, accuracy, and completeness of submissions.
• Manage lifecycle maintenance and post-approval changes across global markets.
• Communicate regulatory expectations and provide leadership to teams.

Conocimientos

CMC regulatory strategy

Regulatory submissions

Regulatory writing

Cross-functional collaboration

Independent project management

Regulatory agency interactions

Timelines & prioritization

Educación

Bachelor’s degree in science

Advanced degree preferred

Herramientas

eCTD knowledge software

Descripción del empleo

Ionis Pharmaceuticals, Inc. seeks an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds in its pipeline.

You will collaborate with CMC RA colleagues, partner companies and vendors to ensure timely, accurate regulatory documentation and approvals. You will lead complex regulatory submissions across multiple regions, manage post-approval changes, and interact with regulatory authorities to support efficient drug