Manager Regulatory Affairs

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
People Leader

All Job Posting Locations:
Gurgaon, Haryana, India

Job Description:

Job Description

 

OVERALL RESPONSIBILITIES:

Work closely with APAC regional Special Project RA lead, global PMOs & Serve as the overall Country Special Project RA lead in IN to execute the MD RA Special Project initiatives.

Serve as a key RA lead by demonstrating strong collaboration skills, partnering with key stakeholders and working with leaders at all levels in the organization

Adherence to J&J CREDO and industry code of conduct, ethics and good regulatory practices, align team members with J&J CREDO.

Ensure 100% compliance with local legislation, global regulatory policies, J&J CREDO.

POSITION DUTIES & RESPONSIBILITIES:


* Lead IN Special Project RA team to develop regulatory strategies for all the special projects by gaining alignments with the internal partners across Johnson & Johnson (including global PMOs, local RA, Supply Chain, Marketing & Quality etc.) to ensure that the stakeholders' voices are evaluated within the strategies


* Provide prioritization, capacity management, and efficiency gain options for Special Project program in IN


* Work collaboratively with country or local Franchise RA leaders to lead executions of all Special Projects


* Be accountable for completing Special Project impact assessments on time


* Be responsible for completing all the RA actions accurately and on time delivery per project plan


* Lead IN Special Project RA team to set project plan with the detailed tasks and timeline for each Special project to avoid any registration misses


* Ensure timely MDRiM updates for each RA action, SEP dates, license update and code linkage to country license per process SOPs


* Be part of APAC Special Project RA leadership team and represent IN to work with the team to create and share the best practices on the Special project executions


* Be responsible to achieve and maintains the appropriate metrics for IN Special Project program per 2025 G&Os


* Recruit and hire Special Projects RA resources as needed


* Ability to manage multiple priorities is required.


* Work across the APAC region to create and share the best practices on the execution of the strategy for executing multiple Special projects


* Ensure applicable company compliance with all rele...