Clinical and Regulatory Analyst - II (Associate)
Posted on: January 27, 2023
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.
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
Keywords: Net2Source, New York , Clinical and Regulatory Analyst - II (Associate), Professions , Kenilworth, New York
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