GRS Manager (Regulatory Affairs Manager)

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

#LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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 adastaffingsupport@bms.com. 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 TAEnablement@bms.com 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)