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GLOBAL PROGRAM REGULATORY MANAGER
 
 
Job Type: Full-Time Discipline: -
Area: Life Sciences
Salary: Not reported
Date added: 16-05-2012
Date of expire: 31-12-2012
Added by: ScienZ Recruiter: India Novartis Healthcare Private Limited
Where: India --> Hyderabad () - Location: India Novartis Healthcare Private Limited



Description

Regulatory Strategy
􀂃 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 (e.g., 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.
2
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 and
commercial objectives of the TPP.
Assists with generating local PIs and ensuring that they are integrated with the CDS, TPP and
regulatory strategy, and are commercially competitive.
Contributes to identifying potential label issues/gaps and develops regulatory label
negotiation strategy with contingency planning.
Revise labels as needed to achieve timely HA approval with best possible label based on
available data.
Responsible for ensuring necessary updates or required reviews of local labeling and to
capture deviations to maintain alignment with the CDS in conjunction with DRA GL.
Regional Excellence and Compliance
Responsible for finalization and on time submission of annual reports and renewals across
assigned regions.
Responsible for appropriate entering and quality of product specific attributes in compliance
database.
Ensures regulatory compliance for assigned project and keeps records of all major HA
interactions in the validated document management system.
Ensures quality and compliance with global regulatory requirements (regions responsible) and
adherence to regulatory internal policies and processes.
Provide support as needed for non-project related regional excellence activities.
Promotional/Non-promotional Review
Reviews promotional and non-promotional materials and press releases as required and
works with DRA GPT representative and/or GTAL to ensure messages are consistent with
Novartis policies and guidelines
junior data analyst and developer
15 Research positions in Computational and Systems Biology
A Postdoc Researcher position in 3D Video Processing
Assistant / Associate Professor - Abdominal Imaging and Obstetric Ultrasound
Animal Experiments 1 & NHP Mgr
Clinical Systems Senior Analyst
Clinical Systems Senior Analyst
Congress and Meetings Project Leader
Formulation Technician
Analyst, iDMA Business Office
Application Manager
Assoc. DSM Third Party Operations (TPO) Manager
Associate DSM Clinical Distribution Manager
OTC/NAH International Information Governance and Management Lead
Pharmacovigilance Expert (Drug Safety and Epidemiology)

Experience with regulatory submission and approval processes in 1 or
more major regions.
Experience in a global/matrix environment or cross-functional teams in
the pharmaceutical industry.
Experience in HA negotiations.
2-4 years involvement in regulatory and drug/biologic development
spanning activities in Phases I-IV in the following areas:
1. Innovation in regulatory strategy.
2. Understanding of post-marketing/brand optimization
strategies and commercial awareness preferred.
3. Involvement in an dossier submissions and approvals
4. HA negotiations.
5. Drug regulatory submission and commercialization in
region.
3
6. Analysis and interpretation efficacy and safety data.
7. Regulatory operational expertise.
􀂃 Strong interpersonal, communication, negotiation and problem solving
skills.
􀂃 Basic organizational awareness (e.g., interrelationship of departments,
business priorities).

Project assistant
Thesis in molecular biology
junior data analyst and developer
15 Research positions in Computational and Systems Biology
A Postdoc Researcher position in 3D Video Processing
Assistant / Associate Professor - Abdominal Imaging and Obstetric Ultrasound
Animal Experiments 1 & NHP Mgr
Clinical Systems Senior Analyst
Clinical Systems Senior Analyst
Congress and Meetings Project Leader
Formulation Technician
Analyst, iDMA Business Office
Application Manager
Assoc. DSM Third Party Operations (TPO) Manager
Associate DSM Clinical Distribution Manager
Global Program Regulatory Manager
OTC/NAH International Information Governance and Management Lead
Pharmacovigilance Expert (Drug Safety and Epidemiology)




 

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