Walk in at
Glenmark Pharmaceuticals Ltd.
Walk-In Location: -
Glenmark Pharmaceuticals Ltd,
Glenmark House, B D Sawant Marg,
Andheri (E), Mumbai 400099
Date: - 4th December, 2019
Time: - 10.00 AM to 3.00 PM
Regulatory Affairs - Sr. Officer / Executive
(US - Filing and Post approval life cycle management)
The objective of the role is working for post
approval activities for emerging markets as per regulatory guidelines.
1. Evaluation
of change control (CC) from manufacturing sites for APIs/Finished
Product/Excipients etc.
2. Renewal
dossiers preparation for emerging markets.
3. Co-ordinate
with different internal and external stakeholders for the data required for
filing of various applications.
4. Evaluation
of proposals related to alternate APIs/excipients/packaging material.
5. Evaluate
various drug product site transfer proposals.
6. Compilation
of Query response related to post approvals.
7. To maintain
post approval database-EDMS.
8. Keep updated
with various guidelines from Health authorities.
Executive - Regulatory Affairs (publishing)
The objective of the role is to mainly
maintain regulatory Database for Emerging Market. The person will be
responsible for ensuring 100% compliance to SOP. To liaise with different stake
holders of emerging market for gathering of regulatory data. Provide technical
review of data or documents that will be incorporated into regulatory database.
Responds to queries of diffident stake holder.
1. Maintain
regulatory database. Actively contribute for data collection, data entry and
peer review.
2. Generate
reports as per requirements, respond to queries from different stake holders.
To support internal and external audits.
3. Keep track
of the product submissions & approvals and variation submissions and
approvals by getting the inputs from different stakeholders.
4. Co-ordinate
with different internal and external stakeholders for the data required to
maintain regulatory database.
5. Perform gap
analysis at the time of data or document receipt, ensure gaps are
closed.
6. Liaise with
overseas offices of Glenmark and other concerned departments to get documents/
data required for maintaining regulatory database.
7. Read various
regulatory updates/guidance' s from health authorities and implement the
same
8. To be aware
of regulatory database and technical requirements for maintaining database. To
give the training to new joiners and stakeholders on Adhoc basis
Regulatory Affairs - Assistant Manager -
Labeling
This role is
responsible for executing the content management of the full range of Europe
Labeling documentation by utilizing regulatory knowledge and expertise to
review, develop and deliver the SmPC, Patient Information Leaflet and or other
reference label texts for all Health Authority Safety Recommendations and Brand
Leader Safety updates. Respond to the deficiency or agency queries on timely
manner.
1.
Responsible for developing, review
and submit SmPC, PIL and artwork for original MAA and Variations by applying
European Labelling regulations, guidelines, and industry standards, ensuring
state of the art E2E Labelling processes.
2.
Acting as Labelling contact person for internal
and external audits and inspections. Applying continuous improvement practices
and processes by anticipating problem areas, looking at current processes, and
developing solutions; escalating issues appropriately
3.
Assess and analysis of HA recommendations/Brand
leader updates with PV and impact assessment of same for updating of labels in
timely with utmost quality .
4.
Responsible for proofreading of labels
ensuring accuracy and consistency against content and redline files and able to
proofread a variety of labeling for spelling, grammar, design and format
consistency. Ability to pay close attention to detail.
5.
To develop and review the of high
quality labeling documentation for all regulatory submissions, following
current best practice standards. Mentoring/training junior team members and
local regulatory and operations staff on End to End Labelling processes &
systems as requested by supervisor.
6.
Applying expert Labelling knowledge,
industry experience, and business needs to provide strategic input to
stakeholders (Reg Affairs, Regional Ops, Artwork, Commercial) for the creation
and execution of all Labelling packaging components and launching plans e.g.
health authority requirements, colour, layout, pack sizes, languages,
branding.
7.
Review and Maintenance of RSI for
Glenmark products
8.
Maintains a positive working
relationship with global internal stakeholders and business partners.
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