Johnson and Johnson Jobs – 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 Immunology therapeutic area.

Job Responsibilities:

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

Job Requirements:

• Project management, oral & written communication skills, organization, and multi-tasking skills
• Regulatory, Clinical or R&D experience with products in early and late development stages
• A PharmD/PhD with a minimum 2 years of relevant experience
• An Advanced/Master’s Degree with a minimum of 4 years of relevant experience
• Experience responding to FDA requests, managing FDA interactions, and lifecycle management of IND/NDA applications
• Direct experience in regulatory affairs
• Understanding of the drug development process
• Understanding of the regulatory submission and approval process
• Able to work successfully within a team environment and as an individual contributor
• A Bachelor’s Degree with a minimum of 6 years of relevant experience
• Previous health regulated industry experience
• Immunology Drug Development experience
• Knowledge of the regulatory environment, US guidelines and practices

Job Details:

Company: Johnson & Johnson

Vacancy Type: Full Time

Job Location: Raritan, NJ, US

Application Deadline: N/A

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