Glenmark Pharmaceuticals Ltd, Walk in 4th
December, 2019 Regulatory Affairs - Sr. Officer /
Executive
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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