Job for Director in Regulatory Affairs at Johnson & Johnson
Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products. The organization is comprised of more than 250 operating companies with over 120,000 employees located in some 60 countries. With Global sales of USD 81.6 billion in 2018, Johnson & Johnson is recognized as one of the most admired and respected companies in the world.
Post : Director - Regulatory Affairs
This role is responsible for managing all facets of regulatory support to J&J products. This includes development of regulatory strategies, providing guidance and consultation for local regulations, interacting with government authority, participating in industry working groups, leading compliance initiatives, managing a staff of regulatory professionals, and managing regulatory projects and budget. An understanding of Johnson & Johnson products and their use as well as an understanding of the regulations and their application is required.
• Overall responsible for regulatory deliverables from initial product registration to EOL for India/ IB Market.
• Works closely with Regional, Country, and Global teams to drive regulatory strategies and initiatives.
• Responsible for all acquired business integration and divestiture project completion as per defined strategy.
• Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.
• Reviews & Approves Regulatory Affairs objectives.
• Submits and administers budget schedules and performance standards
• Plans and manages Regulatory Affairs budget, resources, and projects. Responsible for oversight and prioritization of departmental tasks and projects. Directs and oversees the work of regulatory professionals, including training, mentoring, and professional development.
• Ensures People Development through internal & external trainings
• Responsible to represent regulatory function in Management Review Meetings
• Ensuring coordination with QA, Medical Affairs and other stakeholders in managing field action/ adverse event reporting to meet local country regulatory requirements.
• Ensuring review of promotional materials for regulatory compliance and act as regulatory expert to develop teams.
• Interface and coordinate with regulatory agencies/competent authorities on submissions, approvals, audits or other issues.
• Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.
• Understands and influences local medical device regulatory environment by leveraging key relationships with regulatory authorities and industry groups. Participates in working groups
• Interprets and applies local regulations to business practices and provides regulatory input, advice, and guidance to the organization.
• Responsible for Regulatory Compliance, which includes:
• Oversees review of label preparation, including relevant internet activities to comply with all relevant internal policies/procedures and local country regulations.
• Coordinates with Business Quality/ Regional QA/Regulatory Compliance Leader on Quality field actions & PMS.
• Sound knowledge MOH set up, drugs act/ medical device rules and import licence Procedure.
• Good understanding of ISO/GHTF regulations.
• Implement QMS systems and generate SOPs in Regulatory affairs department and align the same with the JJMI quality system.
• Graduate / Post Graduate- Life science/ Bio Medical/ Pharmacy
• Minimum 15- 20 years Industry Experience in Regulatory Affairs, preferably in medical devices.
• Experience in People development and management.
• Experience in manufacturing and regulatory affairs in medical devices.
• Experience of Submitting, Registering and maintaining Product registrations with Global Regulatory Authorities.
• Professional training as well as RAC certification a plus.
• Understanding of protocols, clinical reports, and dossier preparation.
• Experience in assembling product dossiers for submission to Regulatory Authorities.
• Good understanding of ISO/GHTF regulations
• Good technical writing and communication skills.
Experience :15- 20 years
Qualification : B.Pharm, B.Sc, M.Sc, M.Pharm
Location : Haryana, Gurgaon
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 15th April, 2019
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