Regulatory Affairs Labeling in India at Jobgether
Job Description
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Regulatory Affairs Labeling Specialist based in India.
Join a global clinical research environment dedicated to improving patient outcomes by ensuring accurate, compliant, and up-to-date medicinal product information. In this role, you will oversee regulatory labeling activities throughout the product lifecycle, from initial assessments to post-approval updates. You will evaluate regulatory changes, coordinate product information revisions, and prepare submissions to Health Authorities across multiple regulatory procedures. Working closely with cross-functional teams and client stakeholders, you will help maintain compliance with evolving regulatory requirements. You will also contribute to labeling quality, submission accuracy, and the timely execution of regulatory commitments. This remote opportunity offers exposure to international regulatory processes, specialized systems, and continuous professional development within a collaborative, patient-focused environment.
AccountabilitiesRegulatory Impact Assessment: Evaluate the regulatory implications of change controls raised in TrackWise for medicinal products registered under Centralized, Mutual Recognition, Decentralized, and National Procedures.
Product Information Management: Create and maintain product information documentation, including the Company Core Data Sheet (CCDS), ensuring scientific accuracy and alignment with clinical and regulatory requirements.
Health Authority Submissions: Prepare and submit regulatory variations, notifications, and renewals, ensuring that documentation meets applicable requirements and submission timelines.
Regulatory Query Management: Review and respond to Health Authority questions related to submissions, coordinating with relevant stakeholders to provide accurate and timely information.
Labeling Coordination: Manage medicinal product labeling updates, including translations, while collaborating with internal teams and client stakeholders to ensure consistency and compliance.
Post-Approval Activities: Coordinate and maintain post-approval regulatory activities in Veeva Regulatory Information Management System (RIMS), including artwork updates and associated documentation.
Planning and Quality Assurance: Organize submission schedules, monitor deliverables against key performance indicators (KPIs), and maintain high standards of accuracy and regulatory compliance.
Cross-Functional Collaboration: Work closely with regulatory affairs colleagues, clinical experts, and client teams to resolve issues, coordinate deliverables, and support efficient regulatory operations.
Education: Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related discipline, or equivalent professional experience.
Professional Experience: At least 6 years of experience in regulatory affairs or regulatory labeling, preferably within the pharmaceutical, clinical research, or healthcare industries.
Regulatory Knowledge: Strong understanding of medicinal product labeling requirements, Health Authority submission processes, and regulatory procedures, including Centralized, Mutual Recognition, Decentralized, and National Procedures.
Clinical and Scientific Expertise: Ability to assess clinical information and apply relevant knowledge when preparing and updating product information documentation, particularly the CCDS.
Technical Proficiency: Familiarity with Veeva RIMS and TrackWise for regulatory information management, change control assessment, and post-approval activities.
Preferred Skills: Experience with the Extended EudraVigilance Product Dictionary (xEVMPD) is an advantage.
Communication: Fluency in English, with strong written and verbal communication skills for preparing regulatory documentation and coordinating with stakeholders.
Planning and Organization: Excellent coordination, prioritization, and time-management skills, with the ability to manage multiple submissions and meet deadlines.
Attention to Detail: A careful, quality-focused approach to regulatory documentation, labeling accuracy, and compliance requirements.
Collaboration and Adaptability: A proactive, patient-focused mindset and the ability to work effectively with diverse teams and client stakeholders in a fast-paced, regulated environment.
Remote Work: Work remotely from India, with opportunities to collaborate with international teams.
Professional Development: Access to continuous learning opportunities and the chance to deepen expertise in regulatory affairs and medicinal product labeling.
Global Exposure: Gain experience working with international regulatory procedures, Health Authorities, and cross-functional stakeholders.
Career Growth: Explore opportunities to broaden your regulatory knowledge and develop your career within a global clinical research environment.
Meaningful Impact: Contribute to the accuracy and compliance of medicinal product information, helping healthcare professionals and patients access reliable information about medicines.
Collaborative Culture: Work alongside experienced professionals in a team-oriented environment that values flexibility, quality, and shared purpose.
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