guerbet asia pacific limited

Regulatory Affairs Supervisor / Manager

null, null, IN

Company: guerbet asia pacific limited

Category: Business and Financial Operations Occupations

Published on 2022-01-12T18:29:01.000000Z

Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients. A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9 PERCENT of revenue dedicated to Research & Development and four centers in France, Israel and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B mid caps) and generated 817 million in revenue in 2019 with a global workforce of over 2,800 employees. Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development. For more information about Guerbet, please go to www.guerbet.com and follow Guerbet on Twitter @GuerbetGroup Regulatory Affairs Supervisor / Manager Job duties General Management Implements locally the Group RA policy, strategy and objectives as defined by the Head of Global Regulatory Affairs Manage the tasks for regulatory affairs, pharmacovigilance, promotional material review on regulatory perspective and support the quality assurance matters. To give quarterly feedbacks & updates about Policies related to DCGI / CDSCO and other regulatory authorities in India & other territories. Regulatory Drive drug & medical device registrations and variations in accordance with relevant regulations and develop the strategy to obtain the product approval within target timeframe Register and keep maintenance of production sites abroad. Keep abreast of regulatory procedure and product changes to ensure products documents are maintained in compliance with local and corporate instruction. Effectively communicate and collaborate with Regional / Corporate RA and Pharmaceuticals team in order to develop Regulatory Strategies & to provide local regulation intelligence to internal stakeholders Maintenance of registration data base locally. Maintain contact with the DCGI & CDSCO regulatory authorities & make regular official visits their offices to keep updated on the latest happenings. Work along with the local Regulatory liaison agent for smooth execution & handover process. Support the Regulatory prices related subjects in collaboration with commercial. Pharmacovigilance Be responsible for Pharmacovigilance including reporting / communication with HQ and authorities. Implement Corporate SOPs, maintain local PV system and update local SOPs Being a role of LRPPV (local responsible person of pharmacovigilance) Ensure all PV related submissions are made & updated on time, in coordination with the HQ Team, Regional Team and in-country team. Work along with the Deputy LRPPV. Quality Management Support the Implementation of corporate SOPs & local SOPs development on GDP and GDP certification & maintenance. Handle quality related questions and complaints Compliance and Administrative Duties Ensure companys products comply with the regulations Plan and coordinate pack changes with related department Validation of promotional material and packaging materials in compliant with local regulation and corporate policy Required Skills & Background Educations & Experiences Pharmacist or related academic background is preferred 5-8 years of relevant experience in pharmaceutical drug registration Experience in medical device registration, quality assurance or pharmacovigilance is favorable. Skills & Qualifications A good working knowledge of legal and regulatory issues Proficient in MS Office, including Word, Excel and PowerPoint Effective communication and interpersonal skills Detail-oriented and independent team player Excellent verbal and written communication skills in English and Hindi. Work precisely according to procedures, rules and regulations Recognize recurring issues and analyze their causes in order to reach a solution

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