Latam Regional Management Center

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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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We are searching the best talent for REGULATORY AFFAIRS SENIOR SPECIALIST (Cross Country) to be in Latin America-Argentina-Buenos Aires/ Other locations: Latin America, other countries (Mexico, Brazil, Chile, Colombia, etc)

Purpose: The RMC Coordinator is a Regulatory Affairs professional with cross-country project responsibility that supports local operating companies in life cycle management of regulatory activities.

You will be responsible for:

- Ambassador of the RMC model with local teams.
- Develop submission plan based on global dispatch, Therapeutic Area expertise and country specific requirements.
- First point of contact for global/regional Regulatory Affairs.
- Collaboration with Global Labeling and RSI.
- Plan and Monitor LOC CMC variation/label change processes from global dispatch to local implementation.
- SPOC with CMC for products under their responsibility.
- Handle content deviation and queries process for Labeling and CMC variations.
- Coordinate translation process together with vendors.
- Performing and/or co-ordination Quality Check (QC) in collaboration with external vendor.
- Act to close gaps in liaison with Regulatory Affairs actors.
- Monitors reference country label approval/translation and dispatch to specialist.
- RMC Specialists (Data Management Center, Labeling and Variation Specialist, Artwork Specialist, others).
- RMC Task owners (collaborate on cross-cluster submission).
- Global Labeling CoE, Global CMC, Regional liaison, LOCs (Experts) for countries in scope.

**QUALIFICATIONS**:

- **Education**:University degree or equivalent by experience
- Approximately of 5 years of regulatory experience preferred in the region.
- Experience of working in a virtual team and/or global organization.
- Previous experience in RA role as Associate, Professional or similar role is of advantage.
- Regulatory Strategy - regional regulatory and legislation knowledge
- Project management.
- Intercultural communication skills.
- Submission knowledge: procedures, timelines, and requirements (cross-countries).
- Good understanding of planning and tracking tools (Insight, WebTCards, LIFT, TruVault, Trackwise).
- Applied Technical Knowledge (Leading). Business acumen (Applying). Decision Making & Priority (Applying). External Focus (Applying). Leading & Influencing (Applying). Persuasive Communication (Applying).
- Language capabilities: fluent in Spanish and English. Portuguese (if possible).

Safe Fleet requirements:
Since this position is eligible for Company Car as working tool, it is also required:

- Valid driver’s license.
- At least 3 years of driving a car experience, preferably in highway zones (between 80 and 110 km/h) and with standard vehicles.