Regulatory CMC Lead, Cell & Gene Therapy

Syneos Health; Buenos Aires; Presencial; ARS 104.200.779 - 133.972.431; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career development and progression

Inclusive culture

Technical and therapeutic area training

Descripción de la vacante

Syneos Health is looking for a Regulatory CMC Manager specialized in cell and gene therapy. This vital role supports the execution of global regulatory CMC strategies, contributes to regulatory submissions, and offers guidance to cross-functional teams. Ideal candidates possess strong interpersonal skills and proficiency in regulatory guidelines.

The position emphasizes strategic thinking, collaboration, and knowledge of cGMP standards, with educational requirements focusing on degrees in Biological sciences. Join us to shape the future of healthcare.

Formación

• Strong interpersonal skills to exchange complex information with others.
• Proficiency in regulatory guidelines like FDA and EMA.
• Experience in preparation and writing of CMC submissions.

Responsabilidades

• Reviews CMC sections of regulatory submissions and responds to regulatory agencies.
• Contributes to development of global regulatory CMC strategies.
• Provides regulatory CMC guidance to cross-functional teams.

Conocimientos

Strong interpersonal skills

Proficiency in regulatory guidelines (FDA, EMA, Health Canada, ICH)

Experience in CMC submissions

Strategic thinking

Problem-solving skills

Collaboration and communication

Planning and prioritization skills

Knowledge of cGMP, FDA, EMA, ICH

Educación

Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs or related life-science field

Descripción del empleo

Syneos Health is looking for a Regulatory CMC Manager specialized in cell and gene therapy. This vital role supports the execution of global regulatory CMC strategies, contributes to regulatory submissions, and offers guidance to cross-functional teams. Ideal candidates possess strong interpersonal skills and proficiency in regulatory guidelines.

The position emphasizes strategic thinking, collaboration, and knowledge of cGMP standards, with educational requirements focusing on degrees in Biological sciences. Join us to shape the future of healthcare.