Johnson and Johnson Careers – Lead Regulatory Scientist

Job Description:

The Lead Regulatory Scientist provides support to the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Neuroscience therapeutic area.

Job Responsibilities:

• Provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy.
• Participate in global regulatory team meetings as appropriate
• Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
• Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
• Act as back-up for contact with Regulatory Agencies as needed
• Draft cover letters for Regulatory Agency communication
• Assist in the preparation of meetings with Regulatory Agencies
• Liaise with LOCs as needed, and ensure responses to queries are made in a timely manner, and that content is consistent with the regulatory strategy
• Assist in the development and improvement of processes related to regulatory submissions.
• Review clinical trial plans and protocols and ensure alignment with regulatory requirements
• Provide regulatory support throughout registration process and life-cycle management
• Advise team in required documents and submission strategies (in collaboration with LOCs as appropriate)
• Assist with timely availability of submission documents and ensure that all document components are in place on time
• Draft and review some document content (depending on level of regulatory knowledge/expertise)
• Prepare, hold and lead cross functional team meetings as appropriate
• Understand submission details and liaise with Submission Management
• Review and approve submission plans

Job Requirements:

• One of the following combinations of education and experience is required: (A) a minimum of a Bachelor’s Degree plus 6 years of relevant experience OR (B) a master level degree plus 4 years of relevant experience OR (C) a PharmD/PhD with 2 years relevant experience
• Previous health regulated industry experience is required
• Understanding of the drug development process is required
• Understanding of the regulatory submission and approval process is required
• Knowledge of the regulatory environment, US guidelines and practices is required
• Direct experience in regulatory affairs is desirable
• Regulatory, Clinical or R&D experience with products in early and late development stages is preferred
• Experience responding to FDA requests, managing FDA interactions, and lifecycle management of IND/NDA/BLA applications is preferred
• Candidate must be able to work successfully within a team environment and as an individual contributor
• Project management, oral & written communication skills, organization and multi-tasking skills are required

Job Details:

Company: Johnson & Johnson

Vacancy Type:  Full Time

Job Location: Philadelphia, PA, US

Application Deadline: N/A

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