Regulatory Affairs Specialist

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At **Janssen **, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of **Johnson & Johnson **, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
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Our patients inspire us.
We collaborate with the world for the health of everyone in it.

We are searching the best talent for **Regulatory Affairs Specialist - Regulatory Affairs / Southern Cone** to be in Buenos Aires.

**Purpose**:As Regulatory Specialist, you will provide support in regulatory activities related to the life cycle of registered products (renewals, post-registration variations, etc.) and will be responsible for the artwork request process of printed packaging materials (labels, leaflets, cases, etc.), for all countries of the South Cluster (Argentina, Chile, Uruguay, Bolivia and Paraguay) and for the follow-up of such requests using an internal artwork management system.

**You will be responsible for**:

- Collaborate in the timely execution of all regulatory activities related to the maintenance of product registrations in LA Sur markets (Argentina, Chile, Bolivia, Uruguay, Paraguay): renewals and post-registration changes.
- Execute all activities of request for creation/change/update of packaging arts required for timely implementation (mock-ups, sales pack, etc), in compliance with a General Plan. Follow up on requests until final artwork is obtained through strong communication.
- Agree and harmonize actions with stakeholders and markets involved. Process inquiries and requests that may arise during the process, obtain the necessary information to process it and manage the response. Plan workload, based on needs and clear definition of priorities.
- Actively participate in new Process Excellence initiatives to optimize the quality of the processes in charge, ensure compliance with country regulatory requirements and ensure timely delivery.
- Collaborate in the maintenance of updated product information in internal and external databases (National Drug Formulary).

**Qualifications**:
**Qualifications and requirements**:

- Degree in Pharmacy, Biochemistry, Biotechnology (or related career).
- English: advanced or upper-intermediate level
- Computer skills: MS Office environment
- 1 year of experience in positions related to regulatory affairs.

**Other Competencies and Skills**:

- Organizational ability to handle multiple activities, planning. Use competent use of time.
- Ability to generate good interpersonal relationships.
- Ability to contribute individually to the success and management of the team.
- Proactive, achievement oriented with flexibility to function in a changing work environment.