Job Details: Regulatory Affairs Project Manager/submissions

Jervis Street
Dublin 1
Regulatory Affairs Project Manager/submissions
Position: Regulatory Affairs Project Manager (submissions)

Brightwater has been retained in the search for a REGULATORY AFFAIRS
PROJECT MANAGER to develop the Management and coordination of
regulatory operations for regulatory submission team with
decentralised set up.

•Representing regulatory submission function in the projects related
to the operational changes, technical projects or the projects driven
by PV department•Compile country specific regulatory intelligence
from Regulatory Affairs Managers responsible for regulatory submission
activities in all EU CIS territories and provide the consolidated
intel on the Regulatory Plan to the stakeholders from other
departments – Pharmacovigilance, Regulatory Compliance, Global
Regulatory •Provide support in respect to registration strategy
(assist in development of regulatory strategy) as well as monitoring
the impact of changing regulatory environment on submission
strategies•Coordinate with regulatory submission team the planned
submissions ensuring that expectations and objectives are shared on
time, documentation required for the submission provided and
submission timelines are met•Plan and monitor of submission date per
market ensuring that registration deadlines are met, track submission
progress through efficient communication to relevant stakeholders and
Regulatory Service Providers (RSPs) and communicate any change in
status or delays •Proactively inform the Head of RA (Europe) and
other involved business units regarding all identified risks related
to the planned MA applications•Coordinate with Regulatory Compliance
the preparation of responses to Request for Information (RFI) received
from Health Authorities to achieve the harmonised registered data
across the countries •Support / Coordinate the data needed to make
all required registration fees in a timely manner•Liaise with other
departments to support the timely introduction of new products into
markets•Assess the impact on existing registered documentation when
new regulatory requirements are issued•Perform assigned tasks to the
highest standard and in accordance with established internal timelines
and guidelines.•Ensure information exchange and periodic reporting
to the Head of RA (Europe) – updating and maintaining regulatory
submission and RFI tracker on a weekly basis•Monitor planned
approval timelines and if necessary, intervene in order to facilitate
approval and minimise registration delays•Raise change controls and
provide regulatory assessment, strategy and regulatory impact
assessment for change controls•Always perform assigned work
according to current good regulatory practice and in compliance with
current legislation and regulatory guidelines •Generate Standard
Operating Procedures and implement where relevant to the regulatory
function•Ensure that accurate records are kept and maintained in a
secure manner as per Good Documentation Practice; ensure proper data
management and archiving•Compile update for Quality Systems
Management Review (QSMR) meetings •Monitoring and reporting on
regular basis the status of regulatory submissions across the region

•High level education such as BSc, MSc, PhD or Pharmacist in Life
sciences or related area•At least **Apply on the website** years in
a similar role in Regulatory in the pharmaceutical industry

Due to the urgency of this vacancy, it is not possible for our client
at this time to consider anyone without the appropriate work permits,
visas or sponsorships already in place. Therefore, we are unable to
consider candidates who do not have full authorisation to work in
Ireland. Applications submitted without the necessary visa in place
will not be considered.

We need : English (Good)

Type: Permanent
Category: Others

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