Associate Director, RA, EPNV

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Bogotá Distrito Capital Colombia Buenos Aires Argentina Mexico City Mexico São Paulo Brazil

Job Description:

Overall purpose of job:

Manages other Managers Supervisors and/or individual contributors in a matrix environment and is accountable for conducting effective performance management and meaningful career development conversations. Collaborates with multiple departments for corporate Regulatory Affairs strategies assessments and policies accounting for new and changing government regulations. Directs resources internally and externally to ensure compliance with regulatory agency regulations and interpretations and advises management on trends in the global regulatory environment.

Essential duties and responsibilities:

• Directs Managers and occasionally individual contributors in a matrix environment and is accountable for meaningful career development conversations and regular coaching and feedback.
• Lead regulatory affairs activities that deliver on the long-term growth strategy for the LATAM region ensuring healthcare providers and their patients have access to our broad portfolio in this important region.
• Provide strategic input throughout the product development process and the entire lifecycle ensuring integration of regulatory affairs requirements with the aim of accelerating market access. This includes establishing connections with Health Authorities through networking and actively engaging with local and regional trade associations shaping the regulations of the future.
• Leads the execution of functional Regulatory Affairs strategies and risk management policies to drive innovation and ensure timely commercialization of new and modified products into key markets.
• Establishes regulatory compliant plans by collaborating with internal stakeholders including Research & Development (R&D) Marketing and other leaders to create cross-functional policies for driving the optimum portfolio of innovative products and pipeline needs.
• Ensures compliance with anticipated regulatory and emerging issues by developing solutions for product development strategies that circumvent potential regulatory challenges.
• Directs the utilization of regulatory knowledge and identified risks in order to bring about process and technical improvements within the organization.
• Develops relationships with thought leaders to influence regulatory policies and positions and drive convergence between future regulatory policy and execution of company strategies.
• Responsible for managing operational aspects of their teams (e.g. budget performance and compliance) as well as implementing workforce and succession plans to meet business needs.
• Proactively creates a purpose driven environment by aligning Johnson & Johnsons Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

Special requirements:

Proficient in English and Spanish languages.

Bachelors degree in pharmacy analytical chemistry biochemistry engineer or a related field.

Deep understanding of regulatory frameworks medical device regulations and processes specific to LATAM countries

Job location:

Latina America

Job Requirements

Essential knowledge and skills:

• Competency in developing regulatory strategies that align with organizational goals and market dynamics.
• Excellent verbal and written communication skills to effectively present regulatory information to diverse audiences.
• Ability to negotiate and advocate for regulatory positions with authorities and internal stakeholders.
• Ability to manage multiple regulatory projects simultaneously with strong organizational skills.
• Experience in timeline management and coordination across cross-functional teams.
• Experience in leading and developing a regulatory affairs team.

Core competencies required for this role:

Team Leadership and Development

Interpersonal and Communication Skills

Strategic Thinking

Effective Communication

Decision-Making and Problem-Solving Abilities

Capacity to work effectively with cross-functional teams (R&D quality assurance marketing) to ensure regulatory compliance throughout the product lifecycle.

Strong commitment to ethical practices and compliance with regulatory standards.

Knowledge of industry standards and practices related to ethical conduct in regulatory affairs.

Negotiation and conflict-resolution skills when dealing with regulatory agencies and during cross-team interactions.

Required Skills:

Preferred Skills:

Business Writing Compliance Risk Developing Others Fact-Based Decision Making Inclusive Leadership Industry Analysis Innovation Leadership Legal Support Managing Managers Operations Management Policy Development Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Strategic Thinking