J&J Hiring in Regulatory Affairs

Location: Gurgaon, Haryana, India
Salary: Rs. 38,000 per month
Experience: 2-6 years

Company Overview:
Johnson & Johnson is a renowned American multinational specializing in pharmaceuticals and medical technologies, traded publicly on the NYSE.

Position Overview:
As a Sr. Executive in Regulatory Affairs, you will play a crucial role in ensuring regulatory and quality compliance across Johnson & Johnson’s medical franchises in India. This includes managing product life cycles, developing regulatory strategies, and coordinating with internal stakeholders for successful submissions to regulatory authorities.

Job Description

1. Position Name: Sr. Executive, Regulatory Affairs
2. Company Name: Johnson & Johnson
3. Department: Regulatory Affairs
4. Qualification: Graduate/Postgraduate in Lifescience/Biomedical/Pharmacy
5. Experience: Minimum 2-6 years of industry experience in regulatory affairs, preferably in medical devices
6. Job Location: Gurgaon, Haryana, India

Job Responsibilities:

• Draft, review, and submit regulatory filings (e.g., re-registrations, new registrations, manufacturer transfers) for the Indian market.
• Prepare and submit other regulatory submissions such as query responses, corrections filings, and post-registration lifecycle management notifications, adhering to regulations and guidelines.
• Update and maintain business plans for assigned franchises/licenses in SharePoint.
• Assist in preparing technical presentations and meetings with regulators.
• Gather and assemble information, and prepare documents for new product applications, renewal applications, change notifications, and responses to regulatory agency questions.
• Maintain changes to regulations, products, and sites, making necessary submissions to maintain compliance.
• Coordinate with internal stakeholders to ensure compliant lifecycle management of products/franchises.
• Maintain the regulatory affairs database for responsible franchises in the MDRIM tool.
• Ensure timely completion of change assessments, quality issues, and corrective actions.
• Create and maintain product registration request forms and change controls.
• Ensure timely archival of regulatory submission documents.
• Participate in the execution of field actions such as product recalls and distribution of field safety alerts, completing assigned tasks promptly.
• Understand and report complaints and adverse events promptly.
• Undertake other assignments as identified and assigned by supervisor/management.

Special Requirements:
You should have strong knowledge of the Medical Device Rule 2017 and the Drugs and Cosmetics Act. Familiarity with international regulations for medical devices in the US and EU is desirable. Proficiency in Medical Device Quality Management System ISO 13485 is also required, along with excellent computer skills and technical writing abilities.

Qualifications:

• Graduate/Postgraduate in Lifescience/Biomedical/Pharmacy.
• Minimum 2-6 years of industry experience in regulatory affairs, preferably in medical devices.
• Experience in submitting, registering, and maintaining product registrations with the Ministry of Health.
• Experience in quality/manufacturing and regulatory affairs in medical devices is advantageous.
• Experience in assembling product dossiers for submission to regulatory authorities.
• Good technical writing and communication skills.