Director, Regulatory Affairs CMC: Global Submissions Leader

Teva; West Chester (Chester County); Presencial; USD 180 000 - 250 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

401(k) with employer match

Paid time off and holidays

Education assistance

Resumo da oferta

Teva is seeking a Director, Regulatory Affairs CMC in the United States to lead regulatory strategies for new molecules and products, coordinating with global teams. You will compile and assess documents for regulatory submissions, interfacing with development, analytical, quality and manufacturing groups across Teva’s network.

You will guide CMC sections of IND/NDA/CTA filings, manage change control, and plan regulatory interactions with FDA, while supporting global registration initiatives

Qualificações

• Bachelor’s degree in scientific discipline
• At least 8 years of pharmaceutical industry experience
• At least 5 years of Regulatory Affairs experience
• Advanced degree (M.Sci., Ph.D., PharmD) preferred
• Experience with FDA, ICH, and regulatory guidelines
• Knowledge of eCTD regulatory filings

Responsabilidades

• Provide regulatory guidance to development teams by interpreting FDA/ICH/EMEA guidelines
• Develop CMC regulatory strategies for development and post-marketing submissions
• Coordinate and review CMC sections of IND, NDA and CTA filings
• Liaise with regulatory counterparts in multiple regions to prepare registration dossiers
• Lead cross-functional product teams for CMC projects and interact with FDA
• Plan and conduct meetings with regulatory agencies as needed

Conhecimentos

Cross-functional collaboration

Regulatory writing

Project management

Clear technical writing

Interpersonal communication

Organizational skills

Formação académica

Bachelor’s degree in scientific discipline

Advanced degree (M.Sci., Ph.D., PharmD) preferred

Descrição da oferta de emprego

Teva is seeking a Director, Regulatory Affairs CMC in the United States to lead regulatory strategies for new molecules and products, coordinating with global teams. You will compile and assess documents for regulatory submissions, interfacing with development, analytical, quality and manufacturing groups across Teva’s network.

You will guide CMC sections of IND/NDA/CTA filings, manage change control, and plan regulatory interactions with FDA, while supporting global registration initiatives