Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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.

The position may be based in Lima-Peru, OR Bogotá-Colombia

Position Summary

The Manager, Global Regulatory Sciences, is responsible for assigned regulatory activities in the Market or Markets in their scope. This role is a Functional Manager, Individual Contributor with no direct reports.

This role will have both hands-on and strategic responsibilities within the BMS Global Regulatory Sciences team.

At BMS Global Regulatory Sciences (GRS) is more than just regulatory requirements. We are a group of innovative, driven individuals, who put the science of our medicines first. We are looking for a like-minded individual who puts team work first, candidates who are willing to challenge the status-quo and modernize the regulatory affairs practice.

Key Responsibilities
 

• Define strategic registration plans for new medicines (Biologics, Small molecules) and new indications.
• Independently manage and prioritize multiple complex projects.
• Plan, prepare and submit regulatory dossiers (New Products, Line Extensions and Lifecycle) to Health Authority.
• Ensure sanitary licenses remain valid and renewal dossiers are submitted on time as per business needs.
• Interact and collaborate with regional and global regulatory affairs functions.
• Lead regulatory interactions with science-based discussions.
• Interface with Health Authority for CMC submissions and CMC-related issues, with guidance and oversight from supervisor/regional/global teams on complex topics.
• Ensure compliance with global BMS policy for management of labeling updates.
• Implement artwork updates according to local requirements and BMS policy.
• Engage, negotiate, and interact with government agencies when required.
• Update internal regulatory systems in compliance with BMS SOPs.
• Maintain local regulatory archiving system.
• Review and approve promotional materials.
• Participate in local trade association meetings.
• Contribute with regulatory documentation for bidding processes.
• Collaborate with in-market quality, distribution, and supply planning teams to ensure medicines are supplied in a timely manner.
• Manage relationships with diverse teams.
• Manage internal and external audits as appropriate.

Qualifications & Experience
 

• Título de Químico Farmacéutico (Pharmacist)
• Minimum 5 years of experience in regulatory affairs in local and/or regional roles.
• Advanced proficiency of English
• Thorough understanding of Chemistry, Manufacturing and Controls.
• Knowledge of ICH/WHO guidelines for pharmaceutical products.
• Thorough understanding of clinical trial design, definition of endpoints and interpretation of safety and efficacy results.
• Critical thinking.
• Problem-solving.
• Teamwork oriented.
• Excellent communication and presentation skills.
• Negotiation Skills.
• IT Literacy.
• Innovative mindset.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.