Regulatory Affairs Specialist

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.

Johnson & Johnson is recruiting for a Regulatory Affairs Specialist located in Mexico City, to work in LATAM Regional Manager Center (RMC).

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 Mexico, 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.

Key Responsibilities:

- 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**:
**Qualifications**:
**Education**:

- University degree or related experience in Pharmaceutical Sciences

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

Experience and Skills:
Required:

- Approximately of 1-2 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.

Preferred:

- Previous experience handling life cycle and safety labeling variations is desired

**Language**:

- Intermediate English is required. Spanish as local language.

Johnson & 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.