Regulatory Affairs Manager

Regulatory Affairs Manager
Empresa:

Bristol-Myers Squibb


Detalles de la oferta

Regulatory Affairs Manager page is loaded Regulatory Affairs Manager Apply locations Buenos Aires - AR time type Full time posted on Posted 3 Days Ago job requisition id R1581237 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. Position Summary: Collaborate in regulatory strategies for submissions of NDA´s and Clinical trials to accelerate new science to patients at the time compliance is respected. 
Execute local country submissions for new registrations, product renewals and variations. 
Ensure regulatory compliance at a local level 
Maintain established brands in line with strategy 
Local team engagement and alignment 
Position Responsibilities Participate in the review and formulation of the 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 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 
#Li-Hybrid 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 ****** . 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.

W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
#J-18808-Ljbffr

Requisitos

Regulatory Affairs Manager
Empresa:

Bristol-Myers Squibb


Line Leader

About the Role Este rol se encargará de liderar y gestionar adecuadamente el proceso productivo a cargo con el fin de asegurar el cumplimiento de los indicad...


Desde Essity - Capital Federal

Publicado a month ago

Jefe De Logística En Transporte

¡Consultores de Empresas te está buscando! Consultores de Empresas se encuentra en la búsqueda activa de Jefe de Logística en Transporte para importante em...


Desde Consultores De Empresas - Capital Federal

Publicado a month ago

Jefe De Taller

Importante Grupo de Concesionario Automotriz, ubicado en la zona de sur de Gran Buenos Aires, más precisamente en Quilmes, se encuentra en la búsqueda de un ...


Desde Importante Empresa Del Sector - Capital Federal

Publicado a month ago

Analista De Control De Gestión Regional

¡Sumate a nuestro equipo! Somos Visma, multinacional líder en desarrollo de software de recursos humanos con presencia en más de 25 países, casa matriz en No...


Desde Vismarg - Finance - Capital Federal

Publicado a month ago

Built at: 2024-05-29T10:40:09.918Z