Manas Singh
Manager, Submission Co-ordination
Bengaluru
Summary
Dynamic and detail-oriented Submission Coordination Manager with a proven track record of 13 years leading complex submission processes. Expert at driving seamless documentation workflows, ensuring regulatory compliance, and meeting critical deadlines without compromising quality. Adept at coordinating cross-functional teams, fostering collaboration, and managing high-stakes projects with precision. Recognized for delivering strategic solutions that optimize operations, reduce inefficiencies, and elevate organizational success. A results-driven leader passionate about turning challenges into opportunities for continuous improvement.
Overview
14
14
years of professional experience
Work History
Manager, Submission Assembly & Publishing
GSK India Global Services Pvt Ltd
10.2019 - Current
- Coordinate, engage & Lead delivery of complex submission packages to agreed schedule and technical specification with stakeholders across GRA, GRPD & Local Operating Companies
- Check compliance of others’ work with requirements and standards as per the market specifications
- Advise and assist customers with more complex or non-routine issues coming out of Assembly work on regular basis
- Support & Lead in setting up of process maps/Guides/QRGs for markets transitioning to implement Assembly process
- Lead the creation and implementation of working practices and procedures aimed at simplifying processes and maintaining quality in Assembly team for various markets
- Identify risks & Lead in preparing action plans in mitigating the identified risks & issues
- Ensure proper Management oversight procedures are in place (Eg: QC process for quality conformance, check lists etc.) to deliver high quality dossiers to various customers
- Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with Assembly team and handle any other work coming out of them
- Supervise and support the work of Submissions Assembly Associates and Specialists
- Manage HR aspects for a team of direct reports including recruitment
- Generate appropriate metrics and key performance indicators for the team, and use metrics to develop and enhance capability in the CoE
- Achievements: Received following GSK Global Employee Recognition awards:
- Employee Recognition 2021-22 Gold award – This award is to recognize the effort in successful migration of the legacy assembly process in Vault
- Gold Award – For successful completion of Brexit project which was submitted well in advance
Regulatory Submissions Specialist – Senior
GlaxoSmithKline Asia Pvt Ltd
08.2016 - 09.2019
- Understanding of regulations, guidelines and developing procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications
- Works across the functions and can work with Stakeholders in development functions in provision of advice interpretation of relevant guidance’s, researching topics and resolving issues
- Drive the submission and delivery process with the Global Publishing team to ensure timely dispatch and archival of submissions as per the agreed timelines
- Dossier review responsibilities for the published packages and approve them prior to dispatch to Health Authorities
- Coordinate & Lead Submission Planning Management Team meetings as required
- With minimal input from manager, executes agreed dossier strategy
- With minimal input from manager, manages multiple project assignments (e.g., Variations, Renewals simultaneously)
- With minimal input from manager, completes data assessment to ensure dossier is fit for purpose
- With minimal input from manager, identifies risks associated with submission data and information packages
- Communicates with line manager to identify issues that have business impact
- May have dossier review responsibilities for peers and may identify improvement opportunities for Regulatory processes, policies and systems
Senior Submissions Specialist - Regulatory Services
PPD
01.2015 - 08.2016
- Provide strategic, expedient, and efficient preparation of client submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements
- Assist in preparing electronic document outputs that meet requirements for regulatory publishing to include documents that work with client and/or regulatory agency software programs meeting consistency and security issues
- Ensure that all final electronic deliverables meet current regulatory electronic document requirements and guidance under general supervision of a manager and assistance as appropriate from a Senior Publishing Specialist
Senior Submissions Specialist
Take Solution Global (LLP)
07.2014 - 12.2014
- Engage other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or barriers to delivery
- Acts independently within a project team to evaluate and deliver publishing tasks
- Ensure successful regulatory review outcomes for product milestones
- Evaluate the publishing needs in relationship to the overall project timelines, quality, and delivery
Document Specialist – Regulatory Submissions
Accenture Life Sciences Pvt. Ltd.
08.2011 - 07.2014
- Bookmarking and Hyper linking the documents
- Carried out pre-publishing activities using ISI Publisher, SmartDeskfor PDF and lifecycle submissions publishing using InSight Publisher for various INDs, NDAs, ANDAs, MAAs, US-Ad Promo Submissions
- Validation of the e-CTD sequences by using Lorenz eValidator, Global Validator
- Perform advanced document management tasks including file transfer, storage, tracking, and archival using eDossier, GDMS
- Perform template conversion and MS-Word document formatting for Clinical publishing activities and document management tasks using FirstDoc
- Build effective working relationships with Regulatory Services Group staff in order to contribute to a well-informed integrated approach to regulation
Education
Master of Pharmacy - Pharmacology
RGUHS
Bengaluru, India 04.2001 -
Bachelor of Pharmacy - Pharmacy
VBSPU
Jaunpur, India 04.2001 -
Skills
Team leadership
Operations management
Strategic planning
Decision-making
Performance management
Staff development
Workforce management
Project management
Cross-functional teamwork
Timeline
Manager, Submission Assembly & Publishing
GSK India Global Services Pvt Ltd
10.2019 - Current
Regulatory Submissions Specialist – Senior
GlaxoSmithKline Asia Pvt Ltd
08.2016 - 09.2019
Senior Submissions Specialist - Regulatory Services
PPD
01.2015 - 08.2016
Senior Submissions Specialist
Take Solution Global (LLP)
07.2014 - 12.2014
Document Specialist – Regulatory Submissions
Accenture Life Sciences Pvt. Ltd.
08.2011 - 07.2014
Master of Pharmacy - Pharmacology
RGUHS
04.2001 -
Bachelor of Pharmacy - Pharmacy
VBSPU
04.2001 -
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