Talent.com
This job offer is not available in your country.
Senior Associate - Regulatory Project and Resource Management

Senior Associate - Regulatory Project and Resource Management

ScaleneWorksBengaluru, Karnataka, India
12 hours ago
Job description

7 - 10 Years of relevant experience in regulatory.

Independently use judgement, strict adherence to GSK and IRM plan quality and process expectations, industry and regulatory standards and drug development experience to deliver high quality integrated Regulatory Development Plans (RDPs) based on input from GRLs and project teams on the overall development strategies associated with projects (asset by indication)

Responsible for maintaining integrated Regulatory Development Plan (RDP) for operationalizing the Global Regulatory Strategy (as defined by the GRL), ensuring regulatory deliverables, timelines, and resource needs are accurately captured for each phase of development

Provide Regulatory functional line planning support at the project level (will support multiple projects under one Asset, if applicable) from Commit to Candidate (C2C) post-approval R&D activities

Manage work packages (add / delete / move as appropriate) within the RDP to ensure the necessary Regulatory deliverables and agreed Global Reg Strategy are reflected; Must understand the importance of RDPs reflecting accurate development strategies through the management of these work packages and associate logic and touchpoints with other plan types

Review and manipulate, as needed, the predecessor / successor logic within the RDP, create scenarios, and communicate what is driving Regulatory deliverable dates to the team and other PMs working on the project

Perform scenario planning through developing alternative planning schedules, for development team and portfolio decision making

Proactively partner with other functional plan owners / project managers from Medical, Safety, Clinical, etc., to ensure awareness of regulatory deliverables and alignment across all plan types within a project group

Support R&D Governance reviews, e.g. Development Review Board (DRB) and Portfolio Investment Board (PIB), at key stage gates in the development process (e.g. C2P2, C2P3, C2F&L) as well as Dynamic Portfolio Review (dPR) facilitate RMT and broader Regulatory review of resource forecasts (both external and internal project expenses EPE, IPE, and FTE); Ensure any requested data is complete, accurate, and fit for purpose for informing business decisions

With support from line managers / RPMs, as needed, build the associated schedules to drive Regulatory resource forecast estimates; forecast cost (EPE) and resource (FTE / IPE) associated with integrated plans

Partner with key stakeholders including PMMT members and functional Project Managers, etc. to ensure plan schedule alignment to intended strategy.

Create a job alert for this search

Senior Associate • Bengaluru, Karnataka, India

Related jobs
  • Promoted
  • New!
Senior Associate I (Project Manager), Research & Development Process & Product Design

Senior Associate I (Project Manager), Research & Development Process & Product Design

IN19 Alcon Laboratories (India) Pvt Ltd CompanyBengaluru, Karnataka, India
Partner with Post-Production Leads to track against a master schedule to manage risk reviews and cascading documentation revisions to support compliance. Reviews status of projects and budgets.Manag...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Regulatory Reporting - Associate

Regulatory Reporting - Associate

Deutsche BankElectronic City, Karnataka, India
The role is to perform a number of key functions that support and control the business in complying with a number regulatory requirements such as Markets in Financial Directive “MiFID II”.This role...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
SAP EH&S Functional Associate

SAP EH&S Functional Associate

Element Solutions IncDevanahally, Karnataka, India
Challenge Yourself and Impact the Future!.Element Solutions Inc (NYSE : ESI) is a leading specialty chemicals company whose operating businesses formulate a broad range of solutions that enhance the...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Scrum Master

Scrum Master

Volvo CarsNandhagudi, Karnataka, India
Software, the fuel for mobility.We bring bold digital visions to life.So we’re on the lookout for more curious and creative engineers who want to create change – one line of high-quality code at a ...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
SAP FTM CoE Functional Expert

SAP FTM CoE Functional Expert

Element Solutions IncDevanahally, Karnataka, India
Challenge Yourself and Impact the Future!.NYSE : ESI) is a global specialty chemicals leader offering advanced solutions across electronics, automotive, industrial finishing, packaging, and energy m...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Senior Associate Patent Analytic

Senior Associate Patent Analytic

CoreIP Legal ServicesBengaluru, Karnataka, India
The primary responsibilities include : .Conducting patent & non-patent literature searches including prior art, freedom to operate, invalidation and other searches. Providing insightful analysis of se...Show moreLast updated: 12 hours ago
  • Promoted
Regulatory Affairs (Veeva-Vault RIM)

Regulatory Affairs (Veeva-Vault RIM)

vueverse.Bengaluru, Karnataka, India
We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets.Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Var...Show moreLast updated: 21 days ago
  • Promoted
  • New!
Regulatory Affairs Associate II

Regulatory Affairs Associate II

Teva PharmaceuticalsBengaluru, Karnataka, India
Teva is seeking a detail-oriented and proactive Regulatory Affairs Labeling Associate to support Canadian regulatory labeling activities. This role is responsible for monitoring Health Canada safety...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Associate HW Component Owner

Associate HW Component Owner

Volvo GroupNandhagudi, Karnataka, India
Transport is at the core of modern society.Imagine using your expertise to shape sustainable transport and infrastructure solutions for the future. If you seek to make a difference on a global scale...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Open-source Software Compliance Coordinator

Open-source Software Compliance Coordinator

Volvo GroupNandhagudi, Karnataka, India
Transport is at the core of modern society.Imagine using your expertise to shape sustainable transport and infrastructure solutions for the future. If you seek to make a difference on a global scale...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Regulatory Affairs Associate Senior 5-7Yrs

Regulatory Affairs Associate Senior 5-7Yrs

Rangam IndiaBengaluru, Karnataka, India
Responsible for publishing, reviewing, archiving, and dispatching eCTD, NeeS or paper regulatory submissions for Devices & Drugs Submissions. Manage and lead regulatory publishing operations for glo...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Regulatory & Cross Product Operations - Associate

Regulatory & Cross Product Operations - Associate

F335 Deutsche India Private Limited, Bangalore BranchElectronic City, Karnataka, India
As part of the Regulatory & Cross Product Ops (RCP) team, you will be responsible for understanding and monitoring various US Regulations as well as tactical and strategic analysis and remediation ...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Senior Regulatory Affairs Associate (Labelling)

Senior Regulatory Affairs Associate (Labelling)

ParexelBengaluru, Karnataka, India
When our values align, there's no limit to what we can achieve.Must have 4-6 years of experience in drug development especially in labeling, product package coordination, clinical supplies / packagin...Show moreLast updated: 12 hours ago
Reg Associate Manager II - LM CD CMC Renewals

Reg Associate Manager II - LM CD CMC Renewals

ScaleneWorksBengaluru, Karnataka, India
Quick Apply
Responsible for chemistry, manufacturing and controls of regulatory matters relating to registrations and / or maintenance of business activities. Prepare sections of registration files, briefing book...Show moreLast updated: 30+ days ago
  • Promoted
  • New!
Tech Specialist - Consolidation

Tech Specialist - Consolidation

Volvo CarsNandhagudi, Karnataka, India
Software, the fuel for mobility.We bring bold digital visions to life.So we’re on the lookout for more curious and creative engineers who want to create change – one line of high-quality code at a ...Show moreLast updated: 12 hours ago
  • Promoted
Senior Regulatory Manager

Senior Regulatory Manager

Biocon BiologicsBengaluru, Karnataka, India
We are looking for a Regulatory Affairs professional with hands-on experience in biologics / biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions.The candi...Show moreLast updated: 22 days ago
  • Promoted
  • New!
Associate II, Complex Gx, Regulatory Affairs

Associate II, Complex Gx, Regulatory Affairs

Teva PharmaceuticalsBengaluru, Karnataka, India
The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U. FDA-regulated sterile complex...Show moreLast updated: 12 hours ago
  • Promoted
  • New!
Associate – Regulatory Reporting Team

Associate – Regulatory Reporting Team

Deutsche BankElectronic City, Karnataka, India
The role is to perform a number of key functions that support and control the business in complying with a number regulatory requirements such as Markets in Financial Directive “MiFID II”.This role...Show moreLast updated: 12 hours ago