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System One Sr Mang / Associate Director Reg Affairs in Florham Park, New Jersey

Title: Senior Manager or Associate Director US Regulatory Affairs for Global Development Projects

Location: Remote

The Senior Manager / Associate Director US Regulatory Affairs for Global Development Projects will participate as a global team member focused on development projects and due diligence efforts.

Diverse duties will include, but are not limited to, participation in development program planning and execution, study teams, and study-related activities; preparation of components of IND and NDA submissions, including regulatory correspondence, and completion of submissions; and performance of Quality Control reviews of regulatory submissions. Will work with the senior staff to develop Regulatory Strategy and Process Improvement initiatives.

RESPONSIBILITIES

  • Provide regulatory strategy and tactical support for assigned projects.

  • Contribute to developing global / regional regulatory strategies for multiple clinical development projects at all stages (Pre-IND through NDA submission and approval).

  • Support and perform with limited oversight larger submissions, such as IND applications and NDAs, including organizing the submission development and review process and timeline, preparing sections, reviewing for completeness, accuracy, and appropriateness.

  • Complete cover letters, FDA Form 1571 and other documentation for submission to FDA as needed.

  • Interpret and advise regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization in order to maximize the business benefit and maintain regulatory compliance.

  • Establish contact with the FDA as required to support developmental programs.

  • Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.

  • Ensure necessary clinical trial information is posted on clinicaltrials.gov, and that all listings are updated appropriately.

  • Be the primary contact for clinical teams for regulatory needs.

  • Contribute to process improvement initiatives that generate sustainable, long-term results which drive efficiency, accuracy, and innovation.

    REQUIREMENTS

  • Bachelor’s degree in Science (e.g. Chemistry, Pharmacy, Biochemistry). Master’s degree in Science related field strongly preferred.

  • Minimum of 5 years of Pharmaceutical industry experience with at least 4 of those years in Clinical Development Operations and Regulatory positions.

  • Working knowledge and experience in regulatory submissions and product life cycle management.

  • Broad range of experience to include Pre-IND and Phase I clinical development through NDA filing is sought (though not necessarily with same compound).

  • Knowledge of drug regulations and guidance's with ability to apply them to complex regulatory issues and requirements.

  • Ability to simultaneously plan, coordinate and lead activities on multiple projects.

  • Ability to self-direct workload, including reprioritizing and delivery under tight timelines.

  • Excellent written and oral communication skills.

  • Detail-oriented team player capable of multitasking and prioritizing.

  • Demonstrate critical thinking efforts.

  • Exposure to due diligence responsibilities is preferred.

  • Adapt to new information, changing conditions, or unexpected obstacles.

  • Proficient in the use of common Microsoft software programs. Exposure to EDMS utilized in document preparation and submissions is preferred.

  • Experience interacting with Health Authorities.

  • Experience developing eCTD-compliant documents.

  • Ability to analyze and communicate scientific information from a broad range of disciplines.

  • Excellent writing, editing, verbal, and interpersonal communication skills, and strong attention to detail.

  • Familiarity with CTD, ICH, GCP, and other standards.

  • Must live a commutable distance to our US Corporate Headquarters

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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