Key Responsibilities:
Regulatory Submissions: Prepare submission dossiers for India import license applications for Radiology medical devices, with support from Global Device Regulatory Affairs teams.
Regulatory Responses: Provide timely, proactive, and systematic regulatory responses to local health authorities, ensuring timely approval for new licenses and proper maintenance of existing ones.
Regulatory Assessments: Provide device regulatory assessments for product development, life-cycle engineering changes, and other relevant areas for India, adhering to timelines set by the Global Regulatory Affairs teams.
Labeling Compliance: Review and ensure the compliance of device labeling materials with local regulatory requirements.
Regulatory Monitoring: Monitor and communicate updates on new or amended regulations in India, assess their impact, and implement appropriate strategies to remain compliant.
Policy Research: Support policy research and activities related to the India device business.
Tracking Regulatory Activities: Develop and maintain tracking systems for regulatory activities, including submission prioritization, submission status tracking, and submission dossier archiving.
Cross-Functional Collaboration: Provide regulatory advice and information to internal stakeholders such as Commercial, Supply Chain, Legal, Quality, and Services teams, from an India regulatory standpoint.
Stakeholder Engagement: Work closely with the APAC Device Regulatory Head, India Commercial team, and Global Device Regulatory Affairs teams to ensure alignment and effective communication.
Experience:
3-5 years of proven regulatory experience in the pharmaceutical or medical device industry, with hands-on experience in India registrations.
Direct working experience with the Central Drugs Standard Control Organization (CDSCO).
Familiarity with local regulations and regulatory assessments for design changes.
Experience in a deadline-driven, highly regulated environment.
Skills & Competencies:
Strong communication skills, both verbal and written, in English.
Proven negotiation skills with internal teams and external parties, including CDSCO.
Detail-oriented and highly organized.
Motivated to work both independently and collaboratively within cross-functional teams.