Interested to explore in different areas of Regulatory Domain
Hi, I’m
Manjunath R
AGM Regulatory Affairs
Bengaluru,KA
Success is not final; failure is not fatal: It is the courage to continue that counts.
Winston S. Churchill
Summary
Resourceful Regulatory Affairs Manager with 20 years of extensive experience in ensuring that company products meet regulatory regulations. Adopt in collecting, collating and evaluating data to provide findings. Accomplished at successfully obtaining licenses for new drugs while ensuring all metrics were adhered to.
Overview
22
years of professional experience
3
Languages
13
years of post-secondary education
Work History
Sterling Lab
AGM Regulatory Affairs
04.2024 - Current
Job overview
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Managed post-approval changes, ensuring all necessary documentation was submitted accurately and on time.
- Streamlined regulatory processes for increased efficiency in submitting drug applications to the regulatory authority.
- Contributed to successful product launches by ensuring all promotional materials met strict regulatory guidelines before distribution.
- Developed training materials for new hires, facilitating knowledge transfer and enhancing overall team competency in regulatory affairs.
- Participated in audits conducted by external agencies, demonstrating professionalism and expertise in addressing any findings or recommendations presented during the process.
- Played an instrumental role in obtaining approval for multiple products by effectively managing filing timelines and deliverables.
- Prepared and submitted regulatory file applications and supporting documentation.
Genpact India (P) Ltd
Sr. Manager
07.2022 - 03.2024
Job overview
- Engaging clients to discuss on the KPIs associated with the process.
- Co-ordinating with stakeholders and strategic partners of the client for the assessment of the changes, submissions and finally closing the actions.
- To provide insights to clients on how to streamline or to improve the process in order to achieve the set targets.
- Review of change control forms as per EMA guidelines
- Guiding team members in preparation of project records (PR) on RIMS for life cycle management.
- Training new entrants on RIMS, creation and customization of events and monitoring of changes in Trackwise.
- Being a change leader, responsible to monitor the changes on Trackwise and ensure action items assigned to action owners are closed within the due dates.
- Change control forms will be routed through source submission & source quality in Veeva Vault and assigning actions.
- Create and customization of events for the changes on source submission in Veeva Vault.
Adcock Ingram
Sr. Manager
05.2017 - 07.2022
Job overview
- Engaging with team on filing strategy discussion related to South Africa and other African projects.
- Coordinate with DMF or ASMF holder for API related issues.
- Review of new submission, deficiency response, variation package and updating RIMS for the respective medicinal products.
- Keeping track on renewal and retention dossier as per the timelines scheduled in their respective regions.
- Guiding team members in preparation of SOP related to RA department on submission or variation filing.
- Training new entrants on RIMS, Docubridge and other relevant applications required on routine basis.
- Review of change control forms as per EMA guidelines
- Keeping track on monograph updates, related guidelines and informing manufacturing sites accordingly.
- Conducting internal training sessions on relevant topics.
- Review of monthly report & team members IPA on quarterly basis.
Apotex Research Private
Group Leader
03.2008 - 05.2017
Job overview
- Responsible for timely review of eCTD applications (solid orals dosage forms) for US, Europe, Canada and Australia regions.
- Review of all technical documents required for submission and deficiency response.
- Training new entrants on RIMS, Docubridge, Docuproof and other relevant applications required on routine basis.
- Responsible to update e-database (RIMS) as and when submission and variations filing has done with authority and appropriate notification will be sent to the respective departments.
- Guiding team members in preparation of deficiency response and updating RIMS for their respective medicinal products.
- Co-ordinating with DMF or ASMF holder for API related issues.
- Responsible for review of change control forms for global markets and variation packages for all SRA regions.
Medreich Limited, Meiji Group
Executive Manager
01.2003 - 03.2008
Job overview
- Responsible for reviewing and submitting registration application of different products in Europe and ROW markets.
- Ensure documents required for submission purpose are reviewed before considering for compilation of dossier.
- Engaging with various departments like R&D, QC, QA and Production for documents required for dossier compilation.
- Updating registered dossiers, evaluating the queries received from respective health authorities, keeping track of renewal & retention of dossiers.
Education
IGNOUNew Delhi, India
MBA from Operations Management
01.2008 - 07.2016
BII NoidaNoida, New Delhi
PG Diploma from Pharma Regulatory Affairs
01.2011 - 07.2012
Bangalore UniversityBengaluru, India
Bachelor of Science from PMS
06.1996 - 06.1999
Skills
Electronic Common Technical Document
Listening to music and playing chess
Listening to music to relax self from work stress and to gain more patience, playing chess to improve on strategic application.
Work Preference
Work Type
Full TimeLocation Preference
On-SiteHybridImportant To Me
Company CultureFlexible work hoursInterests
Accomplishments
- Supervised team of 11 staff members.
- submitted 5 products of Para IV filing to US in same month with accuracy and efficiency with team of 5 members and well accepted without any validation errors.
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Software
Veeva Vault
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