SALAMTULLAH
Dehradun
Summary
Proactive Drug Regulatory Affairs Manager with over 12 years of experience in comprehensive dossier preparation and regulatory submissions across multiple regions including GCC, ASEAN, and African countries. Expertise in leading regulatory compliance projects, ensuring accuracy in documentation, and maintaining timelines effectively. Successfully coordinated with cross- functional teams to secure marketing authorizations, demonstrating a keen ability to navigate complex regulatory landscapes. Committed to leveraging regulatory expertise to contribute to the success and compliance initiatives at any forward-thinking organization.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Manager Drug Regulatory Affair
Verve Human Care Laboratories
Dehradun
08.2022 - Current
- Review & compilation of Dossier (eCTD/CTD/ACTD) as per regulatory guidelines and its review to get the marketing authorization in ROW countries GCC (Saudi Arabia & Oman) ASIAN (Malaysia, Thailand, Vietnam & Philippines) African countries (Botswana, Ethiopia, Nigeria, Uganda, Rwanda, Zambia, Zimbabwe, Kenya, Ghana & Tanzania) Latin America (Coast Rica, Ecuador, Bolivia & Guatemala) Jordan, Iraq, Haiti & Sri Lanka.
- Planning, preparation and submission of dossiers for Renewal and variations (labeling review, new indication, change of manufacturer and/or primary packaging site and/or release site, change in primary packaging material, shelf-life extension, change of specification limits, etc.)
- Reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements
- Reviewing drug substance/drug product section of all dossiers prepared from others team members.
- Review of drug master file (DMF) from the API supplier of new products.
- Review of Process validation report BMR, MFR and art-work (Label, carton, inserts)
- Review of the documents such as stability protocol & reports, specifications and test methods which are part of regulatory submission as per requirements.
- Query response preparation in reference to product registration.
- To keep track of project timelines and deadlines.
- Assists in the management of project timelines and provides operational regulatory support to project teams and Senior Management.
- Maintaining of corporate databases (archiving of regulatory submissions, creation of submission mock-ups and production artworks, etc.).
- Co-ordination and follow up with R&D, QA, QC and Production for collection of technical data for compilation of Dossiers.
Asst. Manager Drug Regulatory Affair
Next Wave (India) Paonta Sahib (HP) India
11.2019 - 07.2022
- Review & compilation of Dossier (CTD/ACTD) as per regulatory guidelines and its review to get the marketing authorization in ROW countries
- ASEAN (Vietnam, Philippines, Myanmar and Cambodia)
- African countries (Uganda, Kenya & Tanzania)
- FWA (Benin, Togo and Mali)
- CIS (Ukraine, Tajikistan, Kyrgyzstan, Kazakhstan and Uzbekistan)
- Latin America (Chile & Guatemala)
- Hong Kong
- (PICs approved plant)
Regulatory Affairs Specialist
Qatar Pharma for Pharmaceutical
07.2017 - 11.2018
- Review & compilation of Dossier (CTD/eCTD) as per regulatory guidelines and its review to get the marketing authorization in GCC countries (Saudi Arabia, Oman, Kuwait & Qatar) Jordan, Sudan & Iraq.
- Doha Qatar
Executive International Drug Regulatory Affairs
Modi Mundipharma Pvt. Ltd.
11.2016 - 06.2017
Executive Drug Regulatory Affairs
Brawn Laboratory
04.2015 - 11.2016
- Faridabad Haryana
Officer Drug Regulatory Affairs
Akums Drugs and Pharmaceutical Ltd & Maxcure Nutravedic
02.2013 - 04.2015
Education
Master of Pharmacy - DRA
R.G.P.V.
Bhopal 07.2010 - 01/2012
Bachelor of Pharmacy - Pharmacy
R.G.P.V.
Satna 07.2006 - 01/2010
Intermediate - Science Education
UP BOARD
Siddharth Nagar 07.2004 - 01/2006
High School - Science Education
UP BOARD
Basti 07.2002 - 01/2004
Skills
- Dossier Compilation
- (eCTD/CTD/ACTD)
- Regulatory Guidelines
- Marketing Authorization Dossier Renewal and Variations
- Labeling Review
- Drug Master File (DMF) Review
- Process Validation Report Review
- Stability Protocol & Reports Review
- Query Response
- Preparation Project
- Timeline Management
- Database Maintenance
- MS Word
- MS Excel
- MS Powerpoint
- Internet
- Creative
- Problem Solving
- Collaboration
- Communication
- Coordination
Languages
- English
- Urdu
- Hindi
- Arabic
Training
- In addition to professional training, Participated in industrial training program of Lapiz Pharmaceutical PVT. LTD. Makraunia Sagar MP
- I got an opportunity to visit Drugs Product Manufacturing plants and research centers. During my Industrial tour of College; I visited 'Unichem, at Goa.
Certification
- Registered pharmacist
Affiliations
• Minor project in M. Pharmacy: “Worldwide comprehensive study of guideline on clinical trial.”
• Major project in M. Pharmacy: “Implication and Implementation of ICH Guidelines in Indian industries.”
Timeline
Manager Drug Regulatory Affair
Verve Human Care Laboratories
08.2022 - Current
Asst. Manager Drug Regulatory Affair
Next Wave (India) Paonta Sahib (HP) India
11.2019 - 07.2022
Regulatory Affairs Specialist
Qatar Pharma for Pharmaceutical
07.2017 - 11.2018
Executive International Drug Regulatory Affairs
Modi Mundipharma Pvt. Ltd.
11.2016 - 06.2017
Executive Drug Regulatory Affairs
Brawn Laboratory
04.2015 - 11.2016
Officer Drug Regulatory Affairs
Akums Drugs and Pharmaceutical Ltd & Maxcure Nutravedic
02.2013 - 04.2015
Master of Pharmacy - DRA
R.G.P.V.
07.2010 - 01/2012
Bachelor of Pharmacy - Pharmacy
R.G.P.V.
07.2006 - 01/2010
Intermediate - Science Education
UP BOARD
07.2004 - 01/2006
High School - Science Education
UP BOARD
07.2002 - 01/2004