Manager, Regulatory Submissions
Posted on: June 12, 2021
Covance by Labcorp is seeking candidates for a Manager,
Regulatory Submissions. The Manager, Regulatory Submissions will be
remotely located anywhere within the United States.
The Manager, Regulatory Submissions will be responsible for
ensuring the timely submissions of appropriate documentation to
Regulatory Authorities globally prior to the performance of
clinical trials, and again prior to marketing of a new
pharmaceutical product, as well as any associated maintenance
This position is responsible for the management of a team of
regulatory professionals and/or responsible for timely
preparation/coordination of regulatory submissions for a particular
project and must work to high standards (governmental, Sponsor,
Covance by Labcorp and self) with minimal supervision. It is the
responsibility of this position to ensure that documents are
prepared to the required standards by maintaining awareness of
current regulatory standards related to drug submissions and
clinical research, and be responsible for providing regulatory
consultancy advice to client companies and/or the Covance by
Labcorp project team.
This position will act as liaison between the client and
Regulatory Authorities. The position requires proactive
interactions with all levels within Covance by Labcorp and clients
and will also be responsible for assisting other Covance by Labcorp
staff in business development activities related to regulatory
This position will provide the highest quality advice on
regulatory issues to members of Covance by Labcorp project teams
and its clients by maintaining awareness of current regulatory
legislation, guidance and practice related to submissions. This
position will evaluate the impact of clinical/regulatory changes on
assigned projects as well as Covance by Labcorp business
- Prepare/review study documentation such as the core EudraCT
Form (Annex I, II & III) and cover letter.
- Coordinate the preparation of high quality submissions (or
parts of submissions) to regulatory agencies for clinical trial and
marketing approval within project timelines. Review of regulatory
documentation prepared by other professional staff and responsible
for the review and critical evaluation of scientific and regulatory
documents intended for submission to Regulatory Authorities.
- Assist in the coordination, collection and organization of data
and information required by Regulatory Authorities.
- Manage projects to the contracted estimate to ensure closing
projects within budget. Regularly monitor project tasks and ensure
that all Out-of-Scope work is documented to ensure Change Orders
are generated as appropriate.
- May represent Regulatory Submissions in new proposal
- Participate in project development and regulatory strategy
planning sessions. Will participate independently in client
meetings and will proactively liaise with clients on regulatory
- Liaise with Regulatory Authorities on behalf of clients.
- Responsible for workload forecasts (resource utilization) for
assigned projects and assistance in the preparation of Time and
Cost Estimates for Regulatory Submissions, projects.
- Provide timely status on assigned projects as required.
- Responsible for ensuring the compliance of deliverables to
applicable regulations, guidance requirements and client
- Responsible for the preparation and maintenance of project
plans for regulatory submission projects and for subsequent
adherence to the plans.
- Participate in training of Covance by Labcorp personnel.
- Assist in the development and updating of Regulatory Submission
- Interact with the Publishing group, Copy Center or equivalent
as necessary for the production of submissions.
- Work on special regulatory projects as assigned.
- Occasional travel may be required.
- Bachelor's Degree in Life Sciences or equivalent, possibly with
a higher qualification.
- Understanding of and ability to determine relevance of
governmental regulatory processes and regulations as they pertain
to investigational drug regulations in particular.
- Minimum of 5 years experience in the Pharmaceutical industry in
Regulatory Affairs or Drug Development.
- Excellent communication, organization and planning skills with
an attention to detail.
- Direct supervisory and project management skills and ability to
Keywords: Covance, Trenton , Manager, Regulatory Submissions, Other , Princeton, New Jersey
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