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Regulatory Affairs Group

Associate Director, Regulatory Affairs

  • Job Title Associate Director, Regulatory Affairs
  • Function Regulatory Affairs Group
  • Sub Function Regulatory Affairs
  • Location Gurgaon, Haryana, India
  • Date Posted
  • Requisition Number 2306147304W
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Description

Business Overview

J&J MedTech India (JJMI)

J&J MedTech India (JJMI) is the market leader in the Medical Technology industry in India. It is in the business of caring and providing solutions to doctors, patients, and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Orthopaedics, Cardio Speciality Solutions, Infection Prevention, Wound Management, Surgical Oncology , Obesity Surgery, Women’s health, Minimally invasive surgery & Circulatory disease management.

        Role Overview

This role is responsible for managing all facets of regulatory and compliance support to J&J MedTech products including any new integration and divestiture project in India 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.

Illustrative 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/Assigned Countries 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 in India.

·       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 market, as per defined strategy

·       Provide the Project teams (in India Cluster) with regulatory input in order 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

Qualifications

Skills, Knowledge and Experience

·       Graduate/ Postgraduate preferably in Pharmacy, Life Sciences or equivalent is required

·       10-12 years Industry Experience in Regulatory Affairs, preferably in medical devices, and biologicals will be added advantage.

·       Knowledge and competency in application of Local regulations D&C Act and Rules, MDR 2017, Legal Metrology, ISO 13485 and other regulatory requirements especially in Quality Systems

·       Good project management skills and the ability to manage multiple complex projects, diverse tasks and to prioritize work effectively is required.

·       Well-developed Regulatory project management execution, communication, and presentation skills.

·       High level of integrity, accuracy, and attention to detail.

·       Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.

·       Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision- making.

·       Demonstrate ability to work successfully in a nimble, fast-paced matrixed environment.

·       Outstanding interpersonal, communication and negotiation skills. Must be fluent (both oral and written) in English.

·       Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook

Key Competencies

Credo based leadership : Demonstrates integrity, inspires trust and avoids conflicts of interest in developing and supporting projects, partnerships and collaborations.

Team Leadership : Enhances team’s effectiveness by taking ownership of team issues and goals.  Actively builds trust and rapport within the team.  Motivates team members to achieve goals.  Ensures knowledge is continuously enhanced and is passed on to others. Take ownership for and/or support talent acquisition, performance and development of self and others. Leverage diverse perspectives, backgrounds and talent.

Innovation : Brings out the innovation and creativity in other people and contributes novel ideas that can transform the business. Translate insights into innovative and viable products or solutions that create value.

Relationship Building / Partnerships Management : Creates genuine partnerships, interacts confidently and employs astute perception with strong listening and questioning skills in complex or less familiar situations

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