Clinical and Regulatory Analyst - II (Associate)

Company: Net2Source
Location: Kenilworth
Posted on: January 27, 2023

Job Description:

Qualifications:

Education: BS / MS degree required with 2 years Regulatory Affairs experience within the pharmaceutical industry. Regulatory/Clinical operations experience preferred, demonstrated leadership skills with ability to work in high performance teams and/or matrix organization. Must be able to collaborate to resolve issues. Must be able to articulate clear operations and regulatory strategy. Preferred skills include an understanding of functional area responsibilities associated with the clinical development process as well as the Regulatory Submissions process. Must demonstrate strong project management, communication (oral and written), and analytical skills. Demonstrated track record of working independently with limited supervision, ability to make data driven decisions. Must have problem solving experience and must effectively manage conflict. Teamwork and the ability to manage in a fast- paced environment with changing priorities. Knowledge of regulatory ancillary document procurement experience desired. Strong interpersonal skills a must. Project management abilities desired. College degree required in a science or business related discipline. ** NOTE: Position is expected to be onsite a minimum of 2 days a week. Candidate can also be local to the Rahway, NJ site. **

Responsibilities:


Regulatory Affairs International Clinical & Registration Specialist role to support regulatory operational aspects of clinical trial applications, marketing applications, and variations. Responsibilities include document procurement, tracking, and fulfillment of ancillary document requests.: The incumbent is accountable for managing the following related to clinical trial applications: Regulatory Affairs International operational aspects of MRL clinical trials in varying stages of development. Effectively liaise with all participating functional areas that are represented at the clinical trial team as well as subsidiary personnel to resolve issues pertaining to Regulatory submissions, approvals, and health authority queries. Work within team environment to maintain regulatory lines of communication within the team. Schedule and lead meetings ad hoc and team meetings to ensure issues are resolved in a timely, efficient manner. Regulatory Registration (marketing applications, and variations): Order all ancillary documents requested by RAI liaisons required to support dossier registrations. This includes maintaining accuracy of the documentation status over time. Attend Regulatory planning meetings upon request of RAI liaison to represent RAI and the status of the ancillary documents for a given market. For non-standard ancillary documents, proactively obtain examples from local RA or country requirements database, and proactively address any items of uncertainty to meet submission timelines. Support ad-hoc requests for CPP and other ancillary document metrics (example, countries requiring a certain CPP type, requirements for filing). Perform other regulatory tasks upon request of supervisor or regulatory team members in need of support. Work within Regulatory systems to maintain documentation as required by assigned projects. Schedule and lead meetings ad hoc and team meetings to ensure issues are resolved in a timely, efficient manner.

Keywords: Net2Source, New York , Clinical and Regulatory Analyst - II (Associate), Professions , Kenilworth, New York