Sr Analyst in Regulatory Affairs - DePuy Synthes

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

São Paulo, Brazil

Job Description:

DePuy Synthes is recruiting for a(n) Sr Analyst in Regulatory Affairs, located in São Paulo/SP.

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Overview

Develops skill set to enable value-added individual contributions, who works under moderate supervision. Implements methods for planning, directing, coordinating, and controlling regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Interprets new and changing government regulations to ensure compliance with regulatory/government standards.

Key Responsibilities

• Implements compliance with regulatory agency regulations by providing knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements.
• Completes thorough analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.
• Applies in-depth knowledge on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets.
• Identifies opportunities on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.
• Completes detailed regulatory submissions required for new and existing product approvals and registrations.
• Communicates Regulatory Affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports to support internal and external audits.
• Coaches more junior colleagues in techniques, processes and responsibilities.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Experience

• Must have 3 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for Brazilian Health Authorities and a successful track record.
• Experience in Medical Devices or Pharma.
• Desirable experience in Orthopedics portfolio.

Education

• A Bachelor’s Degree in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience.
• Advanced reading, writing and speaking Skills in English are required. Fluent in Portuguese.

 

 

Required Skills:

 

 

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