REGULATORY AFFAIRS MANAGER

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:
Mexico City, Mexico

Job Description:

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 https://www.jnj.com/innovative-medicine

Essential Job Duties and Responsibilities:


* Develop and implement regulatory strategies for product registration, approval, and post-market compliance in Mexico.


* Prepare and submit regulatory filings to Mexican regulatory authorities, including new drug applications, variations, renewals, and responses to queries.


* Involvement in ODDs and Advanced therapies strategies.


* Monitor changes in Mexican regulatory requirements and ensure company compliance with applicable laws, regulations, and guidelines.


* Collaborate with internal departments, including R&D, Quality Assurance, Marketing, Commercial, Trade Operations and Legal to support regulatory activities and product development initiatives.


* Serve as the primary point of contact for regulatory agencies in Mexico, representing the company in meetings, negotiations, and communications.


* High technical knowledge in FDA and EMA marketing authorizations.


* Conduct regulatory risk assessments and provide recommendations to senior management on regulatory matters impacting product development and commercialization.


* Maintain accurate and up-to-date regulatory documentation, including registration dossiers, regulatory submissions, and correspondence with regulatory authorities.


* Provide training and support to internal stakeholders on regulatory requirements, processes, and best practices.


* Navigate in complex matrices, including regional and global.

 


* External shaping with Regulatory Authorities.


* People management & development.


* CREDO & Compliance behaviors.

Minimum Qualifications:


* B.S.

in Science, Engineering, or Technical subjects.


* 8 to 10 years of experience in Regulatory Affairs


* Min.

2 years of experience leading teams


* MBA or M.Sc.

is desirable.


* Excellent verbal and wr...