GRS Manager (Regulatory Affairs Manager)

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley.

Collaborate with regulatory strategies for submissions of NDA´s and Clinical trials to accelerate new science to patients at the time compliance is respected.

Collaborate with local country submissions for new registrations in accordance to business need.

Ensure regulatory compliance at a local level

Maintain established brands in line with strategy

Local team engagement and alignment.

Position Responsibilities

• 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

Degree Requirements

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

Experience Requirements

• More than 7 years in Pharma Industry

Key Competency Requirements

• Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work.
• Fluent in English
• Good communication and interpersonal skills
• Strategical agility

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https //careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606295 GRS Manager (Regulatory Affairs Manager)