Glenmark Pharmaceuticals Ltd, Walk in 4th December, 2019 Regulatory Affairs – Sr. Officer / Executive (US – Filing and Post approval life cycle management)
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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.
- Evaluation of change control (CC) from manufacturing sites for APIs/Finished Product/Excipients etc.
- Renewal dossiers preparation for emerging markets.
- Co-ordinate with different internal and external stakeholders for the data required for filing of various applications.
- Evaluation of proposals related to alternate APIs/excipients/packaging material.
- Evaluate various drug product site transfer proposals.
- Compilation of Query response related to post approvals.
- To maintain post approval database-EDMS.
- 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.
- Maintain regulatory database. Actively contribute for data collection, data entry and peer review.
- Generate reports as per requirements, respond to queries from different stake holders. To support internal and external audits.
- Keep track of the product submissions & approvals and variation submissions and approvals by getting the inputs from different stakeholders.
- Co-ordinate with different internal and external stakeholders for the data required to maintain regulatory database.
- Perform gap analysis at the time of data or document receipt, ensure gaps are closed.
- Liaise with overseas offices of Glenmark and other concerned departments to get documents/ data required for maintaining regulatory database.
- Read various regulatory updates/guidance’ s from health authorities and implement the same
- 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.
- 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.
- 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
- 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 .
- 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.
- 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.
- 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.
- Review and Maintenance of RSI for Glenmark products
- Maintains a positive working relationship with global internal stakeholders and business partners.
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube