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Indegene LifeSystems Pvt Ltd
  Company Profile
Indegene's suite of scientific content, media, and technology services is at the heart of our clients' communication and education initiatives. Our services span the product life cycle and help clients reach out to physicians, health care providers, patients, employees, regulators, and other stakeholders with their key scientific, educational, medical, and marketing messages.
Our services include

* Scientific Competitive Intelligence Services
* Regulatory Writing and Safety Services
* Learning Solutions
* Medical Communications and MedEd Programs

 
  Job Details 
Title: 

Regulatory Submission Manager - Bangalore

Posted On:  12/27/2018 10:04:54 PM
Designation: 

Regulatory Submission Manager

No. of vacancies:  2
Qualifications:  Bachelors Degree
Essential Skills: 
Not specified
Minimum Total Experience:  4
Job Tenure:  Full-time Only
Salary Offered:  DOE
Job Location:  Bangalore Karnataka India

  Job Description
1. Operational Responsibilities

Responsible for submissions of regulatory dossiers to Health Authorities, Worldwide.

Oversee all aspects of submission management, ensuring development and delivery of regulatory dossiers to Health Authorities, Worldwide.

Execute operational tasks including submission planning, document receipt, translation management, technical build and submission to Health Authorities.

Responsible for delivery of all regulatory submissions per submission milestones in compliance with applicable regulatory requirement.

Responsible for managing gross margin, project profitability, CSAT and ESAT.

2. Team Management

Accountable for building capabilities in regulatory submissions.

Responsible for building processes, and developing people to execute on these plans.

3. Process Management

Responsible for building capabilities and processes in managing programs and client expectations.

Driving execution while adhering to systems and processes laid down by the company/ division.

Work and interact extensively with clinical and regulatory experts, and other stakeholders to ensure high quality and timely submissions of regulatory documents for regulators worldwide.

Desired Profile Job Specification:

1. Education Minimum Graduate Degree

2. Experience 3-5 years experience in Pharmaceutical Regulatory

3. Technical Expertise Ability to demonstrate thorough knowledge of FDA, ICH and GCP guidelines and knowledge of submission of documents in accordance with current regulatory standards.

4. Skills and Competencies Should have excellent operational capabilities and team management skills. Should have the ability to build great relationships with internal and external clients.

  Contact Information
Name:  Srihari .
E-mail ID:  srihari.s@indegene.com
Telephone Number: 
Address: 

Reference Name (If Any): 





 
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