Regulatory CMC Strategist - Cell Therapy, Berkeley (Remote)

Bayer AG; Berkeley (CA); Presencial; USD 219 000 - 328 000; Tempo integral

Resumo da oferta

Bayer seeks a Senior Regulatory CMC Strategist to lead global CMC strategies for cell therapy programs and provide regulatory leadership to CMC teams. The role reports to senior management with matrix collaboration across Regulatory, Quality, Development, and Manufacturing functions.

Ideal candidates hold an advanced scientific degree and have extensive experience with US/global submissions, Health Authority interactions, and a track record of leadership in complex regulatory programs.

Qualificações

• Advanced scientific degree required (PhD, MSc, PharmD).
• Extensive regulatory CMC experience in biotech/pharma, including cell therapy.
• Experience with US/global regulatory submissions (IND/CTA/MAA/BLA).
• Strong leadership in matrix team environments.
• Ability to travel up to 20% (US/Canada, limited EU travel).

Responsabilidades

• Represent Regulatory CMC and lead matrix teams for cell therapy programs.
• Develop and implement robust, innovative CMC strategies for cell and gene therapy.
• Lead CMC-related Health Authority interactions, including briefings and responses.
• Partner with QA, Analytical Development, Manufacturing, Clinical, and Regulatory Strategy teams.
• Identify and address regulatory risks, deficiencies, changes, and strategic issues.
• Monitor global regulations and communicate risks and opportunities to leadership.
• Build relationships with agencies, contractors, and industry groups; mentor colleagues.

Conhecimentos

Regulatory CMC leadership

Global submissions

Stakeholder communication

Team leadership

Regulatory strategy

English fluency

Travel readiness

Formação académica

Advanced scientific degree (PhD/MSc/PharmD)

Descrição da oferta de emprego

Bayer seeks a Senior Regulatory CMC Strategist to lead global CMC strategies for cell therapy programs and provide regulatory leadership to CMC teams. The role reports to senior management with matrix collaboration across Regulatory, Quality, Development, and Manufacturing functions.

Ideal candidates hold an advanced scientific degree and have extensive experience with US/global submissions, Health Authority interactions, and a track record of leadership in complex regulatory programs.