Job title: Sr. Specialist/Expert Regulatory Labeling
Company: Merck Group
Job description: A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the wo
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your role: 1.Populate the USPI (& other labelling documents like IFU) with the information provided from Reference Product Information/Company Core Data Sheets into USPI: a) Coordinate with multi-discipline labeling teams Global US Regulatory leads and Labelling leads for adaptation of changes in USPI, presenting labeling implementation strategy and reaching consensus on proposals. b) Coordinate with US Regulatory Lead and Uruguay Hub to ensure approved label artwork is initiated and changes tracked. 2- Provide regulatory intelligence, upon request, analysis of competitor labeling in the relevant therapeutic area & Support collection and processing of data based on request of local strategist 3- Support in labeling negotiations with regulatory agencies, answer to questions or authority request. 4- Manage tracker, change history along with supporting documents and corresponding version management/ Ensure consistency with corporate labeling 5- Initiate and/or contribute to Veeva collaboration workflow including preparation and upload of documents to ensure key deliverables are met as per defined timeframe. 6-Maintain products labelling and change documents 7- Ensuring consistent use of updated templates as per FDA guidance and the requirements enforced time to time. 8-Ensure support to stakeholders, bringing high level in markets insights to regulatory intelligence supporting HA and market trends. 9-Act as SME for the US labelling& LCM activities. Impact Coordinate labeling implementation that supports the safe and effective use of the product that meets the company’s strategic requirements. Lead & enable representatives from all major disciplines involved in US (e.g., Medical, GPS regulatory) to reach agreement on the best competitive labeling for the product. Drive high level collaboration and decision making based on intelligence and market insights. Who you are: Education Degree in a Pharmacy, Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree) Experience & Competencies 7-10 years of overall work experience in Pharma environment Competent authority or Academia/R&D experience related to the role Minimum 3-5 years of Labeling experience Good understanding of Labeling processes and Regulatory Affairs in general. Thorough knowledge of US regulatory & labelling requirements pertaining to life cycle management of authorized products, Knowledge of labeling requirements in other regions Ability to think strategically, to perform root cause analysis and to propose and drive continuous improvement Location: Electronic City, Bangalore What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life! Curious Apply and find more information at
Location: Bangalore, Karnataka
Job date: Sat, 19 Mar 2022 23:19:25 GMT
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