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Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ).
City and state must be separated by a comma followed by a space (e.g., Houston, TX ) J&J Family of Companies Regional Manager, Regulatory Affairs in Bogotá Distrito Capital, Colombia At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional Job Description: You will be responsible for: Performing the preparation, submission, and maintenance of filings.
Collaborating with senior department members to expedite commercialization of new technologies, new indications, and line extensions.
Providing early inputs to identify barriers and needs to craft global development plans.
Interpreting local and international requirements.
Providing support to cross-functional teams and representing the company in interactions with authorities and industry associations.
Collaborating with teams of varied strengths to ensure alignment and consistency in strategies and submissions.
As the Regulatory Affairs Manager, you will play a crucial role in making a significant impact on public health and contributing to the successful access of innovative therapies for the LATAM population, being part of a team that values excellence, collaboration, and continuous learning.
Qualifications - External Education Required: Licenciatura or Bachelor's degree Experience Required: At least 6 years of experience.
Strategic mindset & solid understanding of requirements and guidelines in the Latin America region.
Experience in leading submissions and interactions with regulatory authorities.
Experience Preferred: Experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry.
Ability to analyze information to develop effective scenario planning, leveraging differentiated strategies, solutions, and opportunities for business growth.
Actively manages customer needs and expectations.
Capabilities to balance multiple projects simultaneously.
Languages: Proficiency in English.
Proficiency in Portuguese and Spanish is desired.
Travel: This position may require up to 10% travel.
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