Associate Regulatory Professional II

2 weeks ago

bangalore, India Lifelancer Full time

The position

  • As Associate Regulatory Professional II, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include:
  • Working closely with various submission teams across the organization and all countries in Europe.
  • Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation (EU CTR) and all changes during the life cycle of clinical trials.
  • Maintaining documents (uploading and QC) in the Clinical Trial Information System (CTIS) and ensuring accurate data about clinical trials.
  • Coordinating responses for requests for information from Health Authorities and Ethics Committees.
  • Ensuring timely submissions in CTIS and contributing to project team decisions.
  • Shaping the future setup of new processes for submitting Clinical Trial Applications (CTAs) in the EU.
  • Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS).

Qualifications

We expect you to have:

  • Bachelor´s degree, masters degree, or Ph.D. in science, pharmaceutical or health science.
  • At least 3+ years of experience in regulatory affairs or clinical trials.
  • Fluent written and spoken English.
  • Vault RIM and Vault Clinical (Veeva platforms) knowledge would be an advantage.

On personal level :

Strong team player.

  • Well organised, structured, and detailed oriented
  • Have solid problem-solving capabilities.
  • Can keep your spirits high even when under pressure.
  • Skilled communicator who can cooperate at any organisational level.
  • Curios and like learning new things.
  • You love data and working in systems.
  • Enjoy working with people online and want to be part of virtual multi-cultural team.

Please use the below link for job application and quicker response.

  • Regulatory Professional II

    2 months ago

    bangalore, India Novo Nordisk AS Full time

    Department: Labelling Operations Are you skilled in graphic design and have experience in regulatory affairs? Are you ready for the next step in your career? We are looking for a Regulatory Professional II to join our Global Regulatory Affairs team in Novo Nordisk. If you have a passion for design and ensuring regulatory compliance, read on and...

  • Regulatory Professional II

    6 days ago

    bangalore, India Novo Nordisk AS Full time

    Department:  RA CMC Diabetes & Obesity Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you...

  • Regulatory Professional

    3 days ago

    bangalore, India Novo Nordisk AS Full time

    Department : RA CMC Diabetes & Obesity Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as...

  • Regulatory Professional I

    2 weeks ago

    bangalore, India Novo Nordisk AS Full time

    Department:  RA CMC Diabetes & Obesity Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you...

  • Regulatory Professional I

    2 weeks ago

    bangalore, India Novo Nordisk Full time

        Department:  RA CMC Diabetes & Obesity   Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you...

  • Regulatory Professional

    3 days ago

    bangalore, India Novo Nordisk Full time

        Department : RA CMC Diabetes & Obesity   Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as...

  • Regulatory Professional I

    1 week ago

    bangalore, India Novo Nordisk AS Full time

    Department: Regulatory Affairs CMC & Device Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you...

  • Regulatory Professional I

    6 days ago

    bangalore, India Novo Nordisk Full time

        Department: Regulatory Affairs CMC & Device   Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you...

  • Senior Regulatory Professional

    1 month ago

    bangalore, India Novo Nordisk AS Full time

    Department: Regulatory Affairs Rare Blood Disorders Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight...

  • Senior Regulatory Professional

    1 week ago

    bangalore, India Novo Nordisk AS Full time

    Department: RA Diabetes Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight deadlines and many...

  • Senior Regulatory Professional

    6 days ago

    bangalore, India Novo Nordisk Full time

        Department: Regulatory Affairs Rare Blood Disorders   Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate...

  • Senior Regulatory Professional

    3 days ago

    bangalore, India Novo Nordisk Full time

        Department: RA Diabetes   Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight deadlines and many...

  • Senior Regulatory Professional

    6 days ago

    bangalore, India Novo Nordisk AS Full time

    Department:  Labelling Operations Are you a graphic designer who would like their work to impact patient’s lives? Do you thrive in a working environment where close collaboration with key stakeholders and having and innovative mindset is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we...

  • Senior Quality Professional II

    2 weeks ago

    bangalore, India Novo Nordisk AS Full time

    Department: R&D Quality GBS, Novo Nordisk Quality GBS Are you passionate about ensuring high-quality processes and products? Do you have experience in quality assurance and regulatory compliance? We are looking for an Senior Quality Professional II - Master Data to join our R&D Quality team at Novo Nordisk. If you are ready for a challenging and...

  • Senior Regulatory Professional

    4 weeks ago

    bangalore, India Novo Nordisk AS Full time

    Department: Labelling Designers Are you a regulatory professional looking for an exciting opportunity in the pharmaceutical industry? Do you have experience in labelling and a passion for ensuring high-quality product approvals? Join our team at Novo Nordisk as an RA Labelling professional and make a difference in the lives of millions of patients...

  • Regulatory Adherence Associate

    1 month ago

    bangalore, India F335 Deutsche India Private Limited, Bangalore Branch Full time

    Description The Regulatory Adherence Associate will be responsible for the governance of Regulatory Assurance and Reporting across CB, IB and CRU including supporting the delivery of risk and control initiatives and participating in risk and control activities. They will work closely with Operations across multiple products and locations to ensure...

  • Senior Regulatory Professional

    2 weeks ago

    bangalore, India Novo Nordisk Full time

        Department:  Labelling Operations   Are you a graphic designer who would like their work to impact patient’s lives? Do you thrive in a working environment where close collaboration with key stakeholders and having and innovative mindset is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we...

  • Senior Regulatory Professional

    3 days ago

    bangalore, India Novo Nordisk Full time

        Department:  Labelling Operations   Are you a graphic designer who would like their work to impact patient’s lives? Do you thrive in a working environment where close collaboration with key stakeholders and having and innovative mindset is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we...

  • Regulatory Operations

    1 month ago

    bangalore, India JPMorgan Chase & Co. Full time

    Are you looking for an exciting opportunity to join a dynamic and growing team in a fast paced and challenging area? This is a unique opportunity for you to work in the Regulatory Operations team to partner with the Business. As a Regulatory Operations - Regulatory Reporting - Associate within the Regulatory Operations CoE, you will cater to private...

  • Senior Regulatory Professional

    2 days ago

    bangalore, India Novo Nordisk AS Full time

    Job Title: Senior Regulatory Professional  Department : Operational Centre of Excellence (OCE) About the department Operational Centre of Excellence also known as OCE is a part of IOSO RA Bangalore, OCE was established in May 2021. The main objective of OCE is to extend their expertise to affiliates to absorb their increasing workload by...