Associate Manager –global Cmc Regulatory

4 days ago

Bengaluru, Karnataka, India Elanco Full time

At Elanco NYSE ELAN - it all starts with animals As a global leader in animal health we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets Were driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals people the planet and our enterprise At Elanco we pride ourselves on fostering a diverse and inclusive work environment We believe that diversity is the driving force behind innovation creativity and overall business success Here youll be part of a company that values and champions new ways of thinking work with dynamic individuals and acquire new skills and experiences that will propel your career to new heights Making animals lives better makes life better - join our team today The purpose of Associate Manager Global CMC Regulatory is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy oversee submission preparation and meet the reporting requirements for the maintenance of registrations approvals of new animal drugs with global regulatory agencies This role may also executes CM C regulatory functions necessary to provide supplements variations renewals and annual reporting requirements for approved products The person must have a strong knowledge of FDA CVM and EMA guidelines with the understanding of developing regulatory strategy in the other major geographical regions Functions Duties and Tasks Maintain a positive collaboration and partnership with internal groups in R D Quality and manufacturing Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco Lead CMC submission preparation to provide high quality submissions to multiple geographies Proactively communicate CMC regulatory strategy key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams Lead and implement all global CMC submission activities for assigned projects products while applying the global strategy into submissions Ensure the required documentation and any content quality and or timelines for global submissions are communicated to the appropriate teams and tracked accordingly Author high-quality CMC documentation for submission applying CMC global regulatory strategies assuring regulatory compliance Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends Core Competencies 5 years in Global Regulatory Affairs preferably within Post-approval CMC Life Cycle Management Strong knowledge of FDA CVM and EMA guidelines Experience with CMC registrations in the US and or Europe Strong communication skills both written and oral Ability to make decisions when there is no clear right or wrong answer Self-starter takes initiative Timeline driven Attention to detail Quality and customer focused mindset Strong organization and an ability to multi-task able to handle multiple projects at different phases of development at the same time Elanco is an EEO Affirmative Action Employer and does not discriminate on the basis of age race color religion gender sexual orientation gender identity gender expression national origin protected veteran status disability or any other legally protected status

  • Global CMC Regulatory Associate

    5 days ago

    Bengaluru, Karnataka, India Eli Lilly Full time US$ 90,000 - US$ 1,20,000 per year

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Expert Regulatory CMC

    2 weeks ago

    Bengaluru, Karnataka, India Merck Specialities Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Your Role:Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role):Databases (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki-handbook) maintenance and their continuous improvement (including liaison with external data providers, as...

  • Expert Regulatory CMC

    5 days ago

    Bengaluru, Karnataka, India Merck Healthcare Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Global CMC Regulatory Affairs Specialist

    4 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time US$ 1,20,000 - US$ 1,60,000

    Regulatory Affairs Manager RoleThis role is ideal for a highly motivated individual with strong knowledge of FDA CVM and EMA guidelines, experience with CMC registrations in the US and Europe, and excellent communication and organizational skills.The successful candidate will be responsible for developing regulatory strategies, overseeing submission...

  • Expert Regulatory CMC

    5 days ago

    Bengaluru, Karnataka, India Merck KGaA Full time US$ 90,000 - US$ 1,20,000 per year

    Job Id291455Bangalore, Karnataka, IndiaJob TypeFull-timeWork Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream...

  • Global Regulatory Affairs Associate

    1 day ago

    Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Job OverviewWe are seeking a detail-oriented professional to support end-to-end submissions for global markets.Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.Contribute to Lifecycle Management activities by helping to compile and review CTD dossier modules.Compile initial dossiers...

  • Associate/ Senior Associate

    3 days ago

    Bengaluru, Karnataka, India Eli Lilly Full time

    At Lilly we unite caring with discovery to make life better for people around the world We are a global healthcare leader headquartered in Indianapolis Indiana Our employees around the world work to discover and bring life-changing medicines to those who need them improve the understanding and management of disease and give back to our communities...

  • Senior Regulatory Affairs Manager

    5 days ago

    Bengaluru, Karnataka, India Biocon Biologics Limited Full time US$ 90,000 - US$ 1,20,000 per year

    JOB DESCRIPTIONWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.RESPONSIBILITIES:• Plan and manage development of high...

  • Global Regulatory Compliance Specialist

    7 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Title: Regulatory Affairs Associate IAbout the Role:We are seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and developing strategies to mitigate potential risks.Key...

  • Regulatory Affairs

    5 days ago

    Bengaluru, Karnataka, India vueverse. Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Position Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includesLifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global...