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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