Manager-2 -regulatory Labelling
6 days ago
Job Title Manager 2 - Regulatory Labelling Business Unit Clinical Development Job Grade G11A 11B Location Gurgaon Mumbai At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys Job Purpose The Global Labelling Lead GLL will ensure the creation maintenance and compliance of global labelling documents throughout the product lifecycle This role is critical for safeguarding regulatory compliance patient safety and consistency of product information across global markets Key responsibilities Develop and maintain Company Core Data Sheets CCDS including Core Safety Information CSI with periodic reviews and updates throughout the product lifecycle Perform labelling content gap analysis through multiple label comparisons Ensure CCDS content is implemented into Local Product Information within required timelines across multiple markets Review and assess local country labels to identify deviations from core labelling and propose topics for cross-functional assessment during periodic reviews Highlight key country label proposals that deviate from CCDS or amendments e g USPI EU SmPC Prepare and review global and regional labelling documents including prescribing information patient leaflets and packaging components Review and approve packaging artworks for compliance with approved labelling and regulatory standards Collaborate with Regulatory Affairs Safety Medical and Commercial teams to ensure alignment on labelling content Support global and local affiliates during implementation of labelling changes Maintain accurate records of labelling changes and approvals ensuring adherence to SOPs and regulatory guidelines Qualification Skill and Competencies Requirements Bachelor s degree in Pharmacy Life Sciences or related field Master s preferred 6-7 years of experience in regulatory labelling and artwork within the pharmaceutical industry Strong understanding of global regulatory requirements for labelling Excellent attention to detail and organizational skills Proficiency in document management systems and artwork tools Strong communication and stakeholder management skills Travel Estimate Job Requirements Educational Qualification M Pharm Experience Tenure 6 to 8 years Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent s
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