GRDM-0, Senior Associate Regulatory Submission M

Job description

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

 

Purpose of the role:

·  Manage and provide follow-up on the preparation and documentation of regulatory dossiers for submission to Health Authorities worldwide.
·  Ensure compliance with Health Authority requirements, functional SOPs, and other internal guidance.
·  Streamline submission processing by guiding and harmonizing across functional area.

 

Main interfaces: (ranked by order of importance):

Internally:

·  Regulatory Project Manager
·  Country Regulatory Affairs (Regional Hubs/REC)
·  Global Regulatory Lead
·  Global Clinical Operations
·  Global Patient Safety
·  R&D Informatics
·  Other Global Regulatory Affairs functions
·  Functions that contribute to Module 3 on Chemical, Manufacturing and Controls
·  Clinical functions
·  Non-clinical functions

Externally: CROs

 

Key tasks and responsibilities:

·  Manage and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle.
·  Create and update submission packages and Submission Content Plans for submissions to Health Authorities.
·  Create and update records in Regulatory Information Management system and ensure submissions are documented properly including tracking of HA questions and documentation of approval and registration details in Veeva Vault RIM.
·  Liaise and follow-up with R&D functions to provide required submission-relevant documents on time and in submission ready format.
·  Validate eCTD output, perform quality checks and submit eCTDs through supported HA gateway
·  Collaborate with submission management and publishing vendors, resolve or coordinate any queries, and perform spot checks on output.
·  Functional oversight of vendors for submission management and publishing.
·  Crisis intervention in case of vendor issues to avoid impact on quality or project timelines.
·  Key contact for eCTD and Publishing expertise.
·  Act as power-user for submission applications (Veeva Vault RIM).
·  Author cover letter and application forms for eCTD lifecycle submissions in close cooperation with the Regulatory Lead.
·  Monitor compliance with submission standards and submission process (internal & external).
·  Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements.

 

Requirements:

Education/languages:

·  Degree in a Life Science or related discipline
·  3-4 years’ experience in Regulatory Affairs or Regulatory Operations.
·  Excellent spoken and written English.

 

Professional skills and experience:

·  Minimum 2 years experience in submission management or publishing in eCTD, NeeS and paper format.
·  Proven ability to handle regulatory applications needed to support the regulatory function according to the role.
·  Strong project management skills, international project experience.
·  Excellent organizational skills, work independently, self-motivated and proactive.
·  Goal-oriented and pragmatic approach to work.

 

Personal skills and competencies:

·  Attention to details.
·  Excellent communication and interactive skills.
·  Excellent interpersonal skills.
·  Strong team player with ability to work with multidisciplinary teams within a matrix and in an international environment.

 

 

What we offer : We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Job Requisition ID:  258263

Location:  Bangalore

Career Level:  D - Professional (4-9 years)

Working time model:  full-time .buttontext3e34be14e841299e a{ border: 1px solid transparent; } .buttontext3e34be14e841299e a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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