Manager, Regulatory Affairs

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:
People Leader

All Job Posting Locations:
Bogotá Distrito Capital, Colombia

Job Description:

The Regulatory Affairs Manager for the LA North region is 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 outstanding strategies for the assets in the market.

 

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 plan. 
•    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 LA North 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 LA North 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.