Regulatory Affairs Executive

**Senior DRA Executive (Regulatory Affairs)** Ø Preparation and reviewing of administrative documents. Ø Preparation and Review of Dossier in CTD,ACTD and ECTD Format. Ø Preparing the SPC and SMPC as per country guidelines. Ø Preparation of Dossier for CIS, Africa countries, Gulf Countries, and south India countries. Ø Review and Making of...

We are seeking a highly motivated and detail-oriented Regulatory Specialist to join our dynamic team within the pharmaceutical industry. This role is essential to ensure that our products comply with regulatory requirements and industry standards throughout their lifecycle. You will work closely with cross-functional teams including R&D, Quality Assurance,...

-Full Time Gurgaon Posted 5 days ago Job title Associate - Regulatory Affairs - Reports to Senior Associate/Astt Manager/Manager - Regulatory Affairs - **Job purpose**: To carry out Regulatory Review and Compilation of Technical documentation & dossiers for - Various Markets in compliance to applicable regulations and guidelines. - **Duties and...

We are hiring Regulatory Affairs Executive for a Medical Device Equipment company. Key skills: Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017 - 2+ years of experience implementing test strategies, test plans and test cases for validation and verification in FDA-compliant medical...

Description Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the...

Who You Are:You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals.How You ContributeManage the full life cycle of regulatory submissions for...

Who You Are:You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals.How You ContributeManage the full life cycle of regulatory submissions for...

**Responsibilities**: - **Regulatory Compliance**: - Stay abreast of current and evolving regulations related to Drug License and FSSAI requirements. - Ensure the organization's adherence to all applicable government regulations and standards. - **Drug License Application**: - Coordinate with regulatory authorities for timely approvals and compliance...

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...

IPL Biologicals is currently seeking a highly skilled and experienced Sr. Manager/Manager Regulatory Affairs to join our team. This critical role will be responsible for ensuring compliance with all applicable regulatory requirements for our biological products. The successful candidate will have a strong understanding of regulatory guidelines and...

Posted: September 2024 **Key Responsibilities**: - Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats. - Setting specifications of API process development, knowledge of litigation related to Drugs and Cosmetics Act. - Filing annual updates and amendments to various regions of...

Quality Systems Management: Develop, implement, and maintain quality systems and processes to ensure compliance with regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). - Document Control: Manage document control processes, including document creation, review,...

About the role Finding better ways to provide the materials the world needs. The External Affairs (EA) team has accountability for engaging external stakeholders to positively shape Rio Tinto’s policy and regulatory environment, enhance our competitive position and build trusted partnerships in our priority markets around the world. With teams and country...

Job Location: Gurgaon (preferable)/Baroda/Mumbai Education: M. Pharm Department: Global Regulatory Affairs Specialty Pharma Job Responsibilities Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU &...

Job Location: Gurgaon (preferable)/Baroda/Mumbai Education: M. Pharm Department: Global Regulatory Affairs Specialty Pharma Job Responsibilities Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU &...

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...

The Opportunity We are seeking a passionate and innovative Manager of NPD and Regulatory Affairs, to lead the development of new health supplement products for the Indian market. You will be responsible for the entire product development lifecycle, from market research and concept generation to product launch and post-launch monitoring. This exciting role...

Who You Are: You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals. How You Contribute Manage the full life cycle of regulatory...

Who You Are: You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals. How You Contribute Manage the full life cycle of regulatory...

Who You Are:You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals.How You ContributeManage the full life cycle of regulatory submissions for...