Regional Regulatory Leader – Latin America (Director)

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:
São Paulo, Brazil

Job Description:

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

We are searching for the best talent for Regional Regulatory Leader to be in São Paulo, BR.

Purpose: The Therapeutic Area Leader in Regulatory Affairs for the Latin America region leads the regulatory science and shapes 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 for assigned therapeutic areas.

This role involves working closely with local regulatory affairs departments in Latin America, global regulatory teams, and other cross-functional partners to ensure compliance with regulatory requirements and the outstanding regulatory strategies for the assets in the market.

Mobilize cross-functional and global teams to shift approaches and adapt strategies that better serve regional regulatory and business priorities.

You will be responsible for:

• Leading and performing the preparation, submission, and maintenance of regulatory filings, such initial authorization to lifecycle applications. 

• Supervising and interpreting local and international requirements. 

• Providing guidance and support to cross-functional teams and representing the company in interactions with authorities and industry associations. 

• Leading and mentoring a team of professionals, providing guidance for their development. 

• Collaborating with teams of varied strengths to ensure alignment and consistency in regulatory strategies and submissions. 

• Staying updated on regulatory trends and changes in the region and communicating their impact to relevant team members. 

• You will lead a Therapeutic Area at Johnson & Johnson Innovative Medicine and play a key role in making an impact in public health while contributing to the success of innovative therapies for the LATAM ...