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 Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Mumbai, India

Job Description:

• Compilation of documents for Registration of Drugs

• Liaise with regional team for supporting documents and dossiers for product registration and for tenders

• Provide inputs of regulatory affairs and ensure HA submissions for PMS and Phase IV studies: Quarterly and six-monthly study reports for PMS studies, clinical reports stability protocols and non-clinical study reports

• Coordination with Regulatory Consultants for the effective submission of application at DCGI

• Archival of dossiers, Approvals and DCGI submission copies

• Providing support in Life Cycle management of registered products

• Managing trackers and supporting tenders by providing various documents from regulatory perspective.

Please note: Candidate is already identified for this role.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Collaborating, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments