Manager, Global Regulatory Sciences

hace 4 semanas

Bogotá Cundinamarca, Colombia Bristol-Myers Squibb A tiempo completo

**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 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.**

**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.**

**Uniquely Interesting Work, Life-changing Careers**

**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 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-1

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