SR REGULATORY AFFAIRS ANALYST

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When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough.

Janssen-Cilag a company of Johnson & Johnson is recruiting a Senior Regulatory Affairs Analyst to join its Regulatory Affairs Area. This position will be responsible for define regulatory strategy and deliver pos variation changes processes, annual report submissions and labeling updates of Brazilian products acting as a focal point (local, Regional and Global). This position should also guarantee the compliance of company procedures and implement processes improvement for Regional activities and local ones. This position based in Brazil is also part of Regional (LATAM) structure.

Capabilities

• Experience in working with limited supervision and able to make independent decisions
• Holistic view of regulatory environment enabling to make significant contributions on projects definitions, impacts and mitigation plans
• 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.
• Ability to develop and maintain working relationships, work successfully within a team environment and as an individual contributor
• Strong interpersonal and communication skills

• Solid knowledge of Brazilian regulation framework mainly regarding post approval changes (synthetic and biological) and labeling.
• Confirmed experience
• Degree in Pharmacy
• Ability to manage multiple tasks and projects simultaneously
• Ability to work in a matrix organization and participate effectively both independently and as part of multiple teams