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Regulatory Affairs Sr. Manager Latam
3 semanas atrás
**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
Bogotá, Distrito Capital, Colombia, Mexico City, Mexico, São Paulo, Brazil
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Li-Hybrid
**We are searching for the best talent for Regulatory Affairs Sr. Manager to be in Sao Paulo (Brazil), Mexico City (Mexico) or Bogotá (Colombia)**
**Purpose**:
**Qualifications / Requirements**:
Responsibilities for the role includes performing the preparation, submission, and maintenance of filings.
Collaborates with senior department members to expedite commercialization of new technologies, new indications and line extensions.
Provides early inputs to identify barriers and needs to craft global development plan.
The role involves interpreting local and international requirements.
Applies critical thinking to assess risks and benefits and evaluate options to make informed decisions.
Additionally, provides support to cross-functional teams, and represents the company in interactions with authorities and industry associations.
Collaborate with teams with wide-ranging capabilities to ensure alignment and consistency in strategies and submissions. This position may or may not include people management but should be committed to champion talent development
Regulatory Sr Managers at J&J innovative Medicine plays a crucial role to make a significant impact on public health developing deep insights into the needs of our patients, customers, markets and communities, belong to a team that values excellence, partnership, and continuous learning.
**Qualifications / Requirements**:
- At least more than 8 years of relevant experience in pharmaceutical industry and/or Health Authorities
- Confirmed experience in leading submissions and interactions with regulatory authorities.
- Additionally should demonstrate a strong ability to adjust strategies, stay positive under uncertainty, and remain focused on goals despite evolving circumstances.
- Solid understanding of requirements and guidelines in the Latin America region is needed.
- Awareness of pricing and reimbursement environment in LA would be desirable.
- Excellent communication and social skills, with the ability to work effectively in a cross-functional environment. -Leadership in driving transformative initiatives at the organizational level, encouraging innovation and continuous improvement.
- Should be able to work independently, handle and supervise multiple projects simultaneously.
- **Proficiency in English and Spanish is required**, and proficiency in Portuguese is a plus.
- **Must be located in Sao Paulo, Mexico City or Bogotá
