Strategic Regulatory Affairs & Quality Compliance (SRAQC) department is responsible for regulatory and quality compliance for the entire Johnson & Johnson Medical franchise in India and IB Countries (SriLanka, Bangladesh, Maldives, Nepal & Bhutan).
This role is responsible for managing all facets of regulatory and compliance support to J&J products including any new integration and divestiture project in IB market. This includes development of regulatory strategies, submissions, reviewing labelling and promotional materials, 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.
- Shape the India BIS standards by working with authorities and source companies.
- Overall responsible for regulatory deliverables from initial product registration to EOL for IB Market.
- Works closely with Regional, Country, and Global teams to drive new registrations and maintain registrations
- Lead & responsible for all acquired business integration and divestiture project completion in the IB market, as per defined strategy.
- Support Transformation project team for timely fillings and remediation’s in IB market.
- Defines, communicates, and implements regulatory strategies and plans
- Directs to comply with QMS, procedures, and controls within Regulatory function.
- Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.
- Plans and manages IB 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
- Ensuring coordination with QA, Medical Affairs and other stakeholders in managing field action/ adverse event reporting to meet local country regulatory requirements.
- Review 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 labelling, 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 and registration Procedure.
- Good understanding of ISO/GHTF regulations.
- Implement QMS systems and generate SOPs.
- Completes other regulatory activities as assigned by Department Head.
Postgraduate - Post Graduate- Life science/ Bio Medical/ Pharmacy
Minimum 14- 16 years Industry Experience in Regulatory Affairs, preferably in medical devices.
Experience in People development and management.
Experience in research/D&D, manufacturing and regulatory affairs in medical devices.
Experience of Submitting, Registering and maintaining Product registrations with Global Regulatory Authorities.
Professional training a plus.
Understanding of product development, protocols, research 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
Johnson & Johnson Private Limited (8080)