Experienced Regulatory Affairs Specialist

**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
Buenos Aires, Argentina, Las Condes, Santiago,, Region Metropolitana de Santiago, Chile

**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.

Li-Hybrid

We are searching for the best talent for **Experienced Regulatory Affairs Specialist to be in Buenos Aires, Argentina or Santiago, Chile.**

**Purpose**:
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 Argentina, Chile, Uruguay, Paraguay and Bolivia focused on labeling process.
Accountability: Execution of the complete LCM regulatory process related to labeling updates. This includes ensuring the accuracy of assessments, dossier preparation, timely submission, and securing approvals, while maintaining compliance with all relevant regulations.

**You will be responsible for**:

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

- Ensure assessment, submission and approval of labeling variations in a timely manner.

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

- Align the labeling according to local strategy.

- Handle any Health Authority query for LCM submissions with applicable stakeholders.

- Notify deviation request for labeling to RMC coordinator and applicable stakeholders.

- 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.

**Qualifications / Requirements**:
**Education**:
University degree or related experience in Pharmaceutical Sciences

Experience and Skills:
Required:
Approximately of 2-3 years of regulatory experience in pharmaceuticals or similar industry.
Proactive team player, able to take charge and follow-through.
Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
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.
Previous experience handling life cycle and safety labeling variations.

Preferred:
Experience handling life cycle and safety labeling variations in Argentina, Chile, Uruguay, Paraguay and Bolivia is desired.

**Language**:
Proficient in Spanish; intermediate/advanced English is required.

Competencies

Strong focus on execution and compliance on submissions/approvals
Adaptability to adjust to regulatory changes.
Effective Communication.
Analytical and data driven decision making.
One team culture and Collaboration within RMC and all collaborators
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.
Accountability.

**Required Skills**:
English Language, Regulatory Experience
**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