• Global Program Regulatory Manager-LCM Jobs in Hyderabad,India

  • Novartis AG
  • Save Job
  • 6 - 9 Years
  • Posted : above 1 month

Job Description:

Job ID 276978BR

Position Title Global Program Regulatory Manager-LCM

Job Description Your responsibilities include, but are not limited to

Responsible for implementing regulatory strategy and managing operational activities for assigned regions Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions Partners with regions to align on regulatory strategy in order to fullfill business objectives Implements RFP across assigned regions Works with DRA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders Works with DRA GPT representative and/or GTAL to interact with regulatory consultants/advisors for strategy input and challenge Represents DRA on or leads sub-teams as required HA Interactions Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL Interacts directly with HAs as appropriate in meetings with DRA GPT representative and/or GTAL Coordinates and plans rehearsals for HA meetings Facilitates preparation and finalization of briefing books Develops and implements plans for timely response to HA requests and coordinates responses May serve as local HA liaison depending on location (eg, FDA or EMA) Submissions and Approvals Responsible for integrating global strategy into regional submissions worldwide Contributes to identification of issues, gaps, and tradeoffs affecting optimal and timely submission and approval Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide Review of global dossier summary documents Contributes to development and implementation of plans to avoid/minimize clock stops during submission review Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs) Participates in negotiations for approvals as required with DRA GPT representative and/or GTAL Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the DRA GPT representative and/or GTAL Prescribing Information Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS)with DRA GPT representative and/or GTAL, consistent with development data

Minimum requirements What youll bring to the role

Masters Degree in Science or Pharmacy with Minimum 4 years to 6 years of relevant experience in Regulatory Affairs

Experience with regulatory submission and approval processes in one or more major regions

Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry

Understanding of post-marketing/brand optimization strategies and commercial awareness preferred Involvement in an dossier submissions and approvals

Demonstrated ability for strategic thinking, maintaining awareness of business impact Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload

Why consider Novartis

750 million Thats how many lives our products touch And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more peoples lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment Where youre given opportunities to explore the power of digital and data Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges

We are Novartis Join us and help us reimagine medicine

Division Global Drug Development

Business Unit REG AFFAIRS GDD

Location India

Site Hyderabad, AP

Company/Legal Entity Nov Hltcr Shared Services Ind

Functional Area Research & Development

Job Type Full Time

Employment Type Regular

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Drug Regulation
Salary : As per Industry Standards
Deadline : 15th Mar 2020

Key Skills:

Company Profile:

Company
Novartis AGarfix

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