Job Description - Regional Regulatory Leader – Latin America (Director) (2406228061W)
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.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson.
Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We are searching for the best talent for Regional Regulatory Leader to be in Mexico City, MX; Bogotá, CO or 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 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 as 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.
Qualifications
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.
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.
Primary LocationOther LocationsOrganizationJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.#J-18808-Ljbffr