Regional Regulatory Leader – Latin America (Director) - 2406211217W

Description

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are searching for the best talent for Regional Regulatory Leader to be in Mexico City, MX; Mendoza, AR; Bogotá, CO; São Paulo, BR or Costa Rica .

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 management 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.

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 or Bachelor's degree

• Experience Required: At least 10 years of experience. Strategic mindset & solid understanding of market, 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.

• Experience Preferred: Experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry. Experience in mentoring and developing regulatory affairs professionals. work independently and balance multiple projects simultaneously, navigating ambiguity and developing a solid strategy that can be executed. 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.

Primary Location Latin America-Mexico-Distrito Federal-Mexico City

Other Locations Latin America-Argentina-Mendoza-Mendoza, Latin America-Brazil-São Paulo-São Paulo, Latin America-Colombia-Distrito Capital de Bogotá-Bogotá, Latin America-Costa Rica

Organization Janssen Cilag de Mexico SA de RL de CV (Comercializadora) (7240)

Travel Yes, 10 % of the Time

Job Function Regulatory Affairs

Req ID: 2406211217W