Senior Regulatory Affairs Expert Lead

Global Regulatory Affairs StrategistKey Responsibilities:Develop and direct global regulatory strategies covering clinical, non-clinical, and CMC aspects.Lead the preparation, review, and approval of submission dossiers for regulatory authorities including US FDA, EMA, Health Canada, Australia's TGA, and ANVISA (Brazil).Provide strategic guidance on...

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.Responsible for prepare and review...

Job Title: Senior Regulatory ExpertKey Responsibilities:Compilation and review of new submissions in eCTD format for Non-oral and Oral products for US, EU, and AUS markets.Evaluation, discussion, and finalization of deficiency responses for US, EU, and AUS markets.Review of formulations at the initial stage of development as per current guidance.Review of...

Regulatory Affairs SpecialistThis is a key role in ensuring regulatory compliance across various product categories. The successful candidate will be responsible for preparing, reviewing and maintaining regulatory documents to meet international guidelines and country-specific requirements.The role involves close coordination with internal teams and external...

Job Overview:As a key member of our Regulatory Affairs team, you will be responsible for the compilation and submission of regulatory documents to various markets, including the US, EU, AU, Canada, IL, and Palestine. You will work closely with stakeholders to review and manage all aspects of dossier compilation, query response, and lifecycle management.About...

Global Regulatory ExpertWe are seeking a highly skilled Global Regulatory Expert to support end-to-end submissions for global markets.This role requires exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key Responsibilities:Prepare Variation documents and/or evaluate post-approval changes in compliance...

**Job Title:** Medical Affairs StrategistAbout the Role:The General Manager of Medical Affairs will lead medical affairs strategies, providing robust medico-marketing support and facilitating collaboration between medical and marketing teams. This role encompasses the development of medical materials, training programs, and evaluation of new products to...

Job Title Executive - Regulatory Affairs Business Unit R D1 Regulatory Affairs Job Grade G12A Location Baroda 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...

Regulatory Affairs AssociateWe are seeking a diligent and experienced Regulatory Affairs professional to support end-to-end submissions for global markets.Key Responsibilities:Prepare variation documents, evaluate post-approval CMC changes, and maintain compliance with global regulatory requirements.Contribute to lifecycle management activities by compiling...

Job Title: Regulatory Compliance ExpertThe successful candidate will be responsible for handling regulatory filings, tariff determination, petitions, and compliance with regulatory frameworks in the power sector.Key Responsibilities:Handling regulatory filings and tariff determinationProviding end-to-end support in regulatory submissionsCollaborating with...