Sr. Manager Regulatory Affairs

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Gurgaon, Haryana, India

Job Description:

This role is responsible for managing all facets of regulatory and compliance support to J&J MedTech Surgery products including any new integration in India. This includes development of regulatory strategies, submissions, reviewing labelling, 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.

Key Responsibilities:

·       Ensure complete regulatory deliverables from initial product registration to EOL (End of Life) for registered products as per defined business plan for India.

·       Works closely with Regional, Country, and Global teams to drive new registrations and maintain registrations for the regulatory projects (Product registration/ Re-registration/ Site transfer/ Discontinuation)

·       Work with regulatory colleagues and partners to determine best practices towards global  registration activities/strategies for implementation as required for the regulatory projects for India

·       Provide leadership and support interactions with local stakeholders to mutually align on regulatory strategies and expectations for major project tasks like regulatory approval for NPIs/NPDs

·       Ensure timely review of RA business plan to ensure business continuity and avoid any business exigency situations

·       Monitoring & Tracking of Regulatory Submissions for India as per business plan.

·       Directs to comply with QMS, procedures, and controls within Regulatory function.

·       Acts as guide/SME to team, subordinate, or staff to help meet established schedules or resolve technical or operational problems

·       Directs and oversees the work of regulatory professionals, including training, mentoring, and professional development

·       Ensuring coordination with QA, Medical Affairs and other stakeholders in managing field action/ adverse event reporting to meet local country regulatory requirements.

·       Ensure timely reporting of regulatory mandatory reports and timely submission of field action/ adverse event reporting

·       Interface and coordinate with regulatory agencies/competent authorities on submissions, approvals, audits or other issues.

·       Interpret existing and/or new regulatory requirements and communicate 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 for policy shaping activities for India Cluster.

·       Shape the India BIS standards by working with authorities and source companies.

·       Interprets and applies local regulations to business practices and provides regulatory input, advice, and guidance to the organization.

·       Lead & responsible for all acquired business integration and divestiture project completion in the India Cluster, as per defined strategy

·       Provide the Project teams (in India) with regulatory input to create quality dossier meeting regulatory requirements and to obtain timely regulatory approvals for the products as part of the regulatory planning

·       Escalation of delayed approvals/ permissions to RA leadership for contingency planning

·       Develop & maintain regulatory knowledge of Local, European regulations (Good understanding of ISO/GHTF) & US regulations specifically for medical devices & ensures compliance with regulatory agency regulations and interpretations.

·       Completes other regulatory activities as assigned by Department Head.

 

 

 

Required Skills:

 

 

Preferred Skills:

Coaching, Compliance Management, Continuous Improvement, Design Thinking, Package and Labeling Regulations, Process Improvements, Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Standard Operating Procedure (SOP), Strategic Thinking, Sustainability, Sustainable Packaging, Technical Credibility, Transparency Reporting