Regulatory Affairs Sr. Manager LATAM

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

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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.
Learn more at

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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: 
Regulatory Affairs Sr. Manager for the Latin America region accountable for the regulatory science and crafting and influencing the strategies to advance projects for early stages of research and develop submissions and approvals for initial marketing authorization applications and lifecycle managements of the products assigned. This role involves working closely with local, global, and other cross-functional partners to ensure compliance with requirements and the outstanding strategies for the assets in the market.

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.
-Candidates should have a consistent track record in regulatory affairs, focusing on the pharmaceutical or biotechnology industry, keeping abreast with trends, developments, technologies and competitive landscape within the health care and pharmaceutical field. 
-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. 
-Candidates should be able to analyze information for the development and implementation of the LA regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives. 
-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