Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Timeline
Personal Details
Hobbies and Interests
Generic

Sunil Kumar Dahiya

Gurgaon

Summary

Passionate about challenges, collaborative learning, helping others, and continuous improvement while delivering the submissions to get registered and have top-notch patient care globally. Seasoned Senior Manager in Regulatory Affairs & Operations with expertise in Process Optimization and Global Publishing. Skilled in RIMS, Vendor Selection Management, Talent Acquisition, and Team Leadership. Experienced in strategic planning, team leadership, and operational management, utilizing comprehensive business acumen to drive efficiency and innovation. Known for creating collaborative environments and delivering high-impact results. Ready to excel in a Senior Manager role by combining deep business operations knowledge with a focus on team success and achieving significant results through adaptability and collaborative problem-solving.

Overview

17
17
years of professional experience

Work History

Senior Manager Publishing

Syneos Health
01.2022 - Current
  • Experience in regulatory affairs and operations spanning more than 17 years.
  • Supporting and overseeing the team of publishers submitting high-quality data to drug regulatory bodies so that patients throughout the world can get the best possible therapy.
  • As a Senior manager, I take care of project related activities, which can involve publishing tools testing to submissions delivery to the client.
  • Provided strong leadership to enhance team productivity and morale.
  • I ensure that issues are flagged appropriately and resolved in a timely manner.
  • Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business.
  • I take part in management meetings and team meetings, cascade the information to the team as required, suggest process improvement where necessary to have robust process.
  • Improved team performance by providing comprehensive training and fostering a collaborative work environment.
  • Collaborated closely with peers from other departments to drive organizational success jointly as one cohesive unit.
  • Reduced costs, optimized resource allocation, and improved efficiency in managing projects.
  • Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
  • I ensure that the client’s expectations are met & high-quality submissions are delivered. Providing training for new team members.
  • Implemented and developed operational standards, policies and procedures.
  • Achieved operational excellence by streamlining processes and implementing best practices.
  • Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements.
  • Directed company's rebranding initiative, refreshing brand image and attracting broader customer base.
  • Developed and executed successful training program for junior managers, equipping them with essential leadership skills.
  • Enhanced digital marketing efforts, increasing online engagement and driving higher sales through various digital channels.
  • Implemented risk management framework, mitigating potential threats to project success and company operations.
  • Successfully managed budgets and allocated resources to maximize productivity and profitability.

Manager Regulatory Operations and RIMS

Syneos Health
07.2012 - 01.2022
  • Develop and maintain quality control processes and optimize publishing process by supporting IT team and Management with lean sigma approach.
  • Helping client in vendor selection for publishing tools and costing.
  • Managing and supporting a team of 15 people in the current project. I am responsible for allocation, compilation, tracking and reporting of the project reports on timely basis.
  • Creating job aids, training checklist, process set-ups, continuous improvement sessions for publishing.
  • Managed and motivated employees to be productive and engaged in work.
  • Provide input and support to assist with process implementation, share/test ideas with clients.
  • Document & Submission Publishing Specialist having experience of IMPD/PSUR/DSUR/IB/Briefing Document/Clinical Reports/Dossiers for IND/NDA/ Renewal dossiers/Variations/Supplements/MAA in Paper/NeeS/eCTD format.
  • Publishing of Renewal dossiers, Variations for Medical Devices for European, US & Canada markets and/or as per client requirement.
  • Submitting outputs to the agencies via ESG Gateway, CESP and EMA portals.
  • Providing updates on a regular basis to the team about upcoming changes in guidance for submission from various drug regulatory agencies.
  • Having responsibilities of Team Lead & PDG Lead, I am providing training to the new joiners and refresher training to the team on regular intervals so that client’s expectations are met and we deliver the quality outputs.
  • Undertake information processing activities with extremely high reliability with high quality and in tight timelines according to standard operating procedures.
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • As a people development lead (PDG), I am responsible for taking care of personal and professional development needs of my PDG members.
  • Involved in recruitment activities, supporting the management in continuous resource planning and in recruitment of candidates for any open slot.
  • Provide support to team members in the execution of their project responsibilities; provide guidance and direction, perform quality checking of the deliverables.
  • Help the team members with day-to-day troubleshooting activities, presenting solutions to project related problems.
  • Participate in meetings with clients on a regular basis to understand the client’s expectations.
  • Identification of risks to project delivery and proper escalation with associated resolution actions.
  • Identify moderate/complex issues and present solutions to project related problems escalated by Associates/ Senior Associates, create Issue log reports & perform RCA of the issues for the management, so that same can be avoided in future.
  • Maintaining regular client interface and building client relationships for ensuring delivery of quality deliverables.
  • Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.

Senior Research Associate (CMC Author and Publisher)

Astron Research Limited (Intas Pharmaceutical)
08.2010 - 07.2012
  • Authoring & Compilation of Dossiers for Generic applications for FDA and Health Canada.
  • Post approval changes to authoring & publishing for USFDA.
  • Drafting Labelling pieces for USFDA and Health Canada.

Regulatory Affairs Executive (CMC Author and Publisher)

Strides Arcolab Limited (Bangalore)
04.2008 - 08.2010
  • ANDA, NDA applications to USFDA (end to end filing of product applications).
  • Creating labeling section documents, PI/Product Monographs/labels as per RLD labels and comparison of RLD and generic drug labeling pieces for the generic applications.
  • Liaison with various departments like Formulation development, Analytical Development, QC, Plant QA, Production, stability and marketing department for compilation of dossiers.
  • Submission of dossiers to USFDA, WHO and MCC & ROW markets i.e CIS, Asian, Latin American countries for generic drug application.
  • CMC & Labeling query responses for generic drug applications, creating clean and annotated labels in response to the deficiencies from regulatory agency.
  • Also gained working experience of post approval changes to the applications.
  • Providing regulatory support to marketing team in Project initiation plans and status updates for regulatory approvals.

Education

Master of Pharmacy - Pharmaceutical Management & Regulatory Affairs

Institute of Pharmaceutical Sciences and Research Center Bhagwant University
Ajmer, Rajasthan

Total Quality Management Certification - undefined

Symbiosis Center for Distance learning

Bachelor of Pharmacy - undefined

Al-Ameen College of Pharmacy

12th - Rajasthan Board

Govt. Sr. Secondry School Nohar
Nohar, Rajasthan

10th - Rajasthan Board

Govt. Sr. Secondary School Nohar
Nohar, Rajasthan

Skills

  • Cross-functional team coordination
  • Operations management
  • Strategic planning
  • Cross-functional collaboration
  • Troubleshooting and problem resolution
  • Veeva Publisher
  • eCTD Express/ISIPublisher
  • PubAssist Tools/Evermap/ISIToolBox
  • eCTDManager
  • Educe solution’s software
  • Pharma Ready
  • Mydoc/Veeva Vault RIM/Veeva AddPromo
  • Extedo's Gecco Solution Validator
  • Rosetta eCTD viewer/Lorenz eCTD validator
  • MS-office applications
  • Adobe Acrobat DC Pro
  • Labeling for Generics
  • Product monographs

Accomplishments

  • Resolved publishing tool issues through consumer testing.
  • Supervised a team of 17 staff members in a single project.
  • Achieved implementation of new publishing tool within 1 month without having an impact on ongoing tasks.
  • Helping clients in user testing of the tools and generating data for any process improvements
  • Member of Indian Leadership team ensuring all management level communications are cascaded appropriately to more than 30 RegOps people.
  • Collaborated with team of 12 publishers in the migration data from of publishing tool
  • Completed 'Generic Drugs Overview' certification at Training and Continuing Education Programs of CDERLearn.
  • Successfully completed the educational video trainings of FDAs Medical Device Initiative & Medical Device Recalls.
  • Won 1st prize in cultural program at Resonance-Vision 2020.

Timeline

Senior Manager Publishing

Syneos Health
01.2022 - Current

Manager Regulatory Operations and RIMS

Syneos Health
07.2012 - 01.2022

Senior Research Associate (CMC Author and Publisher)

Astron Research Limited (Intas Pharmaceutical)
08.2010 - 07.2012

Regulatory Affairs Executive (CMC Author and Publisher)

Strides Arcolab Limited (Bangalore)
04.2008 - 08.2010

Total Quality Management Certification - undefined

Symbiosis Center for Distance learning

Bachelor of Pharmacy - undefined

Al-Ameen College of Pharmacy

12th - Rajasthan Board

Govt. Sr. Secondry School Nohar

10th - Rajasthan Board

Govt. Sr. Secondary School Nohar

Master of Pharmacy - Pharmaceutical Management & Regulatory Affairs

Institute of Pharmaceutical Sciences and Research Center Bhagwant University

Personal Details

  • Date of Birth: 18th Sep 1984
  • Gender: Male
  • Nationality: Indian

Hobbies and Interests

  • Hindi Versification
  • Travelling
  • Cultural exploration allows me to engage critically with diverse perspectives, fostering empathy, global awareness, and nuanced understanding of human experiences.

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Sunil Kumar Dahiya