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 https://www.jnj.com

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

Job Description:

Purpose: Regulatory Affairs Manager for the Latin America region being responsible for the regulatory science and crafting 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.

• 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.

• Interpreting local and international requirements.

• Additionally, provides support to cross-functional teams, and represents the company in interactions with authorities and industry associations.

• Collaborate with teams with varied strengths to ensure alignment and consistency in strategies and submissions.

Qualifications

• Bachelor’s degree completed

• Proven ability 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.

• Solid understanding of requirements and guidelines in the Latin America region is needed.

• Be able to analyze information to develop effective scenario planning. Uses this information to prioritize those scenarios and respond proactively to customer needs and to further the company's strategy.

• Confirmed experience in leading submissions and interactions with regulatory authorities.

• Excellent communication and interpersonal skills, with the ability to work optimally in a cross-functional environment.

• Be able to work independently and balance multiple projects simultaneously.

• Proficiency in English and Spanish is required, and proficiency in Portuguese is a plus.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility