Experienced RA Professional Lifecycle Submission

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 jnj.com.

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:

Professional

All Job Posting Locations:

Bogotá, Distrito Capital, Colombia

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

Johnson & Johnson is recruiting for a Experience RA Professional Lifecycle Submission LATAM located in Bogota, Colombia, to work in Cross-Regional Operations & Strategy Support (C-ROSS).

Position summary:

This is a Regulatory Affairs professional with local/regional responsibility. The role purpose is to be responsible for the end-to-end process execution of regulatory lifecycle management (LCM) in LAN countries (Colombia, Ecuador and Peru), focused on post-registration process.

Accountability: Execution of the complete LCM regulatory process related to post-registration (variations) updates. This includes ensuring the accuracy of assessments, dossier preparation, timely submission, and securing approvals, while maintaining compliance with all relevant regulations.

Key Responsibilities:

• Prepare submission-ready dossier based on local requirements and J&J standards and procedures.

• Ensure assessment, submission and approval of CMC variations in a timely manner.

• Monitoring of Company regulatory submissions/approvals.

• Be first point of contact for LCM with the local Regulatory Affairs colleagues.

• Handle any Health Authority query for LCM submissions with applicable stakeholders, ensuring the robustness of the response.

• Continuous communication, integration and alignment with local team (i.e. RA, Supply, CQ, AW responsible, etc) of the countries in scope.

• Responsible for RA databases related to LCM.

• Archiving all relevant documents from submissions and approvals.

• Participate in Trade Association meetings and internal meetings with different departments, contributing and adding knowledge.

• Assessment of the impacts of new legislation, risks and opportunities and develop a robust plan for implementing new legislation.

Qualifications

• Bachelor's degree in Pharmacy is required.

• Approximately of 3-4 years of regulatory experience in pharmaceuticals or similar industry.

• Experience of working in a virtual team and/or global organization.

• Strong in data gathering, and interpretation with proficient use of technology including RA systems.

• Proficient in Spanish - Advanced English is required.

• Strong focus on execution and compliance on submissions/approvals.

• Adaptability to adjust to regulatory changes.

• Effective Communication.

• Analytical and data driven decision making (preferably without supervision).

• One team culture and Collaboration within C-ROSS and all stakeholders.

• Innovation and Continuous Improvement: skills in problem-solving, critical analysis, and the ability to identify and implement process improvements.

• Agility and curiosity for continuous learning: Eagerness to learn and expand regulatory knowledge for other countries/clusters.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork