Associate Manager Regulatory Affairs Job In Novo Nordisk In Bengaluru / Bangalore, India

Job description Purpose of the job Manage Regulatory Intelligence (legislation and guidelines within the pharmaceutical/healthcare industry) and local regulatory plans Ensure regulatory approvals, license to operate aligned with local business demands Overview of local PV requirements, timely reporting, and maintenance of safety reporting to local HA as per local reporting timelines and handling customer complaints Position's key accountabilities

• Ensure maintenance of RA IT systems used in Novo Nordisk
• Influence and monitor local regulatory environment and ensure compliance
• Provide regulatory support and insight to external and internal stakeholders
• Develop Affiliate level regulatory strategy and Implementation Plans (IPs)
• Develop local RA teams

PV Responsible (Affiliate PVRP) & PVoI Nature and scope ofMain accountabilities

• Ensure maintenance of RA IT systems used in Novo Nordisk

• • Ensure that RIMS activities for Regulatory Affairs are carried out in compliance with established procedures
  • Manage local disposition in Vault RIM and ensure that all affiliate's data in Vault RIM is complete, accurate and on time, aligned with Health Authorities' submissions.
    
    
  • Ensure RIMS training to Regulatory Affairs department
  • Work with colleagues in the affiliate, the Region and Headquarters on projects and initiatives supporting RIMS activities

• Influence and monitor local regulatory environment and ensure compliance

• • Assist Regulatory Affairs Team in assuring Novo Nordisk compliance with internal SOPs and local regulations
  • Explore internal and external regulatory intelligence for the preparation and submission of regulatory documents, tracking submission status for corporate database
  • Monitor and evaluate local regulatory landscape e.
    
    g, HA's communications/rules/guidelines for information pertinent to Novo Nordisk business
  • Maintain up-to-date general knowledge of local guidance and regulations to facilitate collection and evaluation of on-going regulatory climate
  • Identify and analyse relevant external intelligence sources eg.
    
    , HAs, pharmaceutical associations, Novo Nordisk's Project, competitor website, and industry publications Provide summaries of the findings to product/project teams
  • Maintain surveillance of regulatory environment and competitor development and provide evaluation to local management, product/project teams and other internal stakeholders

• Provide regulatory support and insight to external and internal stakeholders

• • Compose letters on Novo Nordisk opinions/position on local Health Authorities' draft guidance, proposed rules etc to provide company's input on regulatory initiatives.
    
    
  • Publish and disseminate intelligence in a timely manner, to relevant groups within RA/CMR, other departments (eg, Legal, Marketing, Sales), Business Area, Headquarters, and other internal stakeholders
  • Maintain an active presence in pharmaceutical associations and similar forums to represent Novo Nordisk's interests
  • Assist supervisors in the coordination of information flow from and to pharmaceutical organisations to promote Novo Nordisk positions in relation to the regulatory environment.
    
    

• Develop Affiliate level regulatory strategy and Implementation Plans (IPs)

• • Create written affiliate level regulatory strategy plans and Implementation Plans (IPs) as needed according to the guidelines provided
  • Coordinate, plan and monitor products' registration, renewals, labelling/packaging changes and updates
  • Fine-tune design of the local New Drug Approval and Lifecycle Management processes
  • Plan and allocate the necessary resources for local Regulatory Affairs
  • Manage the budget for Regulatory Affairs in the Affiliate
  • Prioritise actions and activities internally and ensure their alignment with business objectives.
    
    
  • Implement plans according to the affiliate's business needs
  • Support the Director and local management in regulatory matters and initiatives across the affiliate

• Develop local RA team

• • Provide the necessary training and mentoring to the Regulatory Affairs' team members
  • Follow up on team members' personal and professional development, providing them with new challenges and responsibilities as well as coaching to overcome possible obstacles

• PV Responsible (Affiliate PVRP) & PVoI

• Monitor local PV requirements, report new/changes PV requirements to Global Safety timely through established NN system, and ensure implementation of new requirements locally
• Acting as an Affiliate PV Responsible (APRP) and the Pharmacovigilance Officer In charge (PVoI)

Purpose and subject of interaction with internal/external customers and key contacts The incumbent will have direct influence over regulatory approvals in the local market, impacting on the reputation and results of the department, contributing to the BA and Novo Nordisk Regulatory Affairs' goals and results.

The position holder will be able to develop high level of trust and confidence with colleagues The incumbent will have the ability to create results through others within the RA teams and/or internal stakeholders, through good training and mentoring skills and a proven capability of managing and influencing groups and individuals Challenges with regard to innovation and change The incumbent will be able to draw out information and make logical/analytical/strategic connections to predict consequence, detect business opportunity and adapt quickly to new situations The incumbent will be highly creative to formulate innovative regulatory ways and benefits but still able to comply with a regulated environment and a structured framework Education requirements M.

Pharm, Pharm-D, MSc Work experience 6-9 years related regulatory affairs experience Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions) Deadline 19th March 2023 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.

We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in Together, we're life changing

Novo Nordisk is looking for .

Novo Nordisk is looking for Any Graduate / Post Graduate profile candidates.