Regulatory Affairs Lead - Global Submissions & Strategy

Bristol Myers Squibb EU Policy; Buenos Aires; Presencial; ARS 121.918.000 - 182.877.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb seeks an experienced Regulatory Affairs professional for a manager-level role in Buenos Aires. Lead regulatory submissions, ensure local compliance, and maintain alignment with global strategies while coordinating with Medical, Supply, Commercial and QA/QC teams.

The role requires a science-related degree, fluent English, and over 7 years in pharma, with strong leadership and strategic agility. Remote/field work models may apply per business needs.

Formación

• Science degree required.
• Fluent English skills.
• Excellent technology profile.
• Transparent communication.
• Team Leader.

Responsabilidades

• Collaborate with country regulatory strategy for new products registration and life cycle management in alignment with business goals.
• Communicate regulatory submission dates, regulatory status, nature of changes, track and inform of minor/significant product information changes to all relevant parties.
• Maintain strong relationships with other functional areas (i.e., Medical, Supply, Commercial, QA/QC).
• Plan and track activities related to regulatory submissions.
• Plan, prepare, submit and follow up new license applications and post approval variations (labeling, CMC).
• Responsible for the in-time review and approval of 100% promotional materials.
• Management of Health Authority (HA) requisitions.
• Identify opportunities to improve departmental functions/processes.

Educación

Science related degree

Descripción del empleo

Bristol Myers Squibb seeks an experienced Regulatory Affairs professional for a manager-level role in Buenos Aires. Lead regulatory submissions, ensure local compliance, and maintain alignment with global strategies while coordinating with Medical, Supply, Commercial and QA/QC teams.

The role requires a science-related degree, fluent English, and over 7 years in pharma, with strong leadership and strategic agility. Remote/field work models may apply per business needs.