Regulatory Affairs Manager — Global Submissions & Strategy

Bristol Myers Squibb; Municipio de Rincón de los Sauces; Presencial; ARS 1.800.000 - 3.200.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb is seeking a Regulatory Affairs Manager in Argentina to lead regulatory submissions and lifecycle management for new products. The role demands strong collaboration with country teams, strategic planning, and maintaining key regulatory relationships to ensure compliance and timely approvals.

Ideal candidates will have a science degree, English fluency, and 7+ years in the pharma industry, with proven leadership and cross-functional communication skills.

Formación

• Science degree and English fluency required.
• Strong regulatory knowledge and leadership experience.
• Excellent communication and interpersonal skills.

Responsabilidades

• Collaborate with country regulatory strategy for new products registration and lifecycle management.
• Communicate regulatory submission dates and status to relevant parties.
• Maintain relationships with Medical, Supply, Commercial, QA/QC.
• Plan and track regulatory submissions activities.
• Submit and follow up license applications and post-approval variations (labeling, CMC).
• Review and approve 100% promotional materials in time.
• Manage Health Authority (HA) requisitions.
• Identify opportunities to improve departmental functions and processes.

Conocimientos

Regulatory knowledge

Leadership

Communication skills

Strategic agility

English proficiency

Educación

Science related degree

Descripción del empleo

Bristol Myers Squibb is seeking a Regulatory Affairs Manager in Argentina to lead regulatory submissions and lifecycle management for new products. The role demands strong collaboration with country teams, strategic planning, and maintaining key regulatory relationships to ensure compliance and timely approvals.

Ideal candidates will have a science degree, English fluency, and 7+ years in the pharma industry, with proven leadership and cross-functional communication skills.