Senior Executive

2 days ago

Borivli, Maharashtra, India Johnson & Johnson Innovative Medicine Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Mumbai, India

Job Description:

Timely submission of registration application and subsequent query responses.

Make local administrative documents as necessary for submission, draft artwork manuscripts for new products, complete LLD process when required.

Liase with global team & local SC team to arrange required FP samples & reference standards required for testing at Governments labs as a part of registration

Responsible for timely renewals and CMC variations

To prepare, draft, collate various applications as necessary as a part of product registration maintenance activity

Asist in all activities pertaining to the clinical trial.

Responsible for maintaining required internal and external compliance standards.

Cross functional collaborations (eg. MAF, SC) to support respective business objectives.

Supporting packaging material specs creation and Artwork development, assisting SME in this area as necessary.

Any other responsibilities assigned by the manager as per available resources.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork

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