Regional Regulatory Leader - Latin America (Director)

ffairs 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://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 population, being part of a team that values excellence, collaboration, and continuous learning.

Qualifications

• Education Required: Licenciatura

• Experience Required: At least 10 years of experience. Strategic mindset & solid understanding of requirements and guidelines in the Latin America region. Strong leadership and management experience. Excellent communication and interpersonal skills, with the ability to work optimally in a cross-functional environment, with critical thinking to solve complex problems. Ability to mobilize cross-functional and global teams to shift approaches and adapt strategies that better serve regional regulatory and business priorities.

• Experience Preferred: Experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry. Experience in leading submissions and interactions with regulatory authorities and ability to analyze information to develop effective scenario planning. Ability to work independently and balance multiple projects simultaneously, navigating ambiguity and developing a solid strategy that can be executed. Ability to demonstrate initiative and creativity to achieve goals and objectives.

• Languages: Proficiency in English is required. Proficiency in Portuguese & Spanish is a plus.

• Travel: This position may require up to 10% of travel.

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