Regulatory Affairs Executive

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,...

**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...

-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...

**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...

**_Job Descriptions: _** - Â- Prepare and review technical documents, and dossiers in the format of CTD/ACTD. _ - Â- Check the compliance status of the Quality Systems. _ - Â- Evaluate and comment on requirements of Clinical studies. _ - Â- Prepare artwork of packaging materials as per current rules and regulations. _ - Â- Must have worked on ASEAN,...

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...

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...

**Roles and Responsibilities** - Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. - Controlling the whole process of registration product from beginning till the end. - Evaluation of Bioequivalence and Clinical Trials (preferably). - **Must be B.Pharm/M.Pharm**: - Having knowledge of ICH guideline. - Having...

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...

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...

**Job Title: Regulatory Compliance & Documentation Officer** Location: Gurgaon, Haryana Department: Quality Assurance & Compliance **About Anadrone Systems**: Anadrone Systems is a pioneer in unmanned systems, delivering cutting-edge aerospace solutions to address complex defence and industrial challenges. We are committed to adhering to the highest...

Axalta has remained at the forefront of the coatings industry by continually investing in innovative solutions. We engineer technologies that protect customers’ products - whether they are battling heat, light, corrosion, abrasion, moisture, or chemicals - and add dimension and beauty with colourful finishes. We have a vast and ever-evolving portfolio of...

**Regulatory Reporting-** Role Description Role will provide Execution Support to IRR-PRA Workstreams Key Responsibilities - Support management in the execution of IRR standards for Large Exposure Returns in scope of PRA Workstreams. - Support where required the successful remediation of the COR002 (COREP Large Exposures) return issue closures. - Support...

**Client**: One of the Big 4 We are hiring experienced professionals specializing in regulatory reporting at banks for our prestigious Big 4 client. This opportunity requires exceptional communication skills and a deep understanding of liquidity reporting, capital adequacy reporting, and related regulatory frameworks. **Responsibilities**: - Act as a...

Job Overview: We are seeking a highly skilled and experienced Government Liaison Officer to join our organization. The Government Liaison Officer will be responsible for establishing and maintaining positive relationships with government agencies at local, state, and federal levels. The primary objective is to ensure effective communication between our...

As a member of the Regulatory Reporting team, you will join a team focused on monthly and quarterly deliverables. The Regulatory Reporting Associate will be responsible for execution of certain SEC Financial Reporting Modernization requirements (Form N-PORT). **Key Responsibilities** - Prepare and review monthly Form N-PORT for all assigned mutual funds...

**COMPANY NAME: - AITMC Ventures Private Limited** **WORK LOCATION: - Gurugram, Haryana - 122002** **COMPANY SERVICES: - Industry 4.0 New age Skill Development Trainings in Drones, Agriculture and Media Overseas employment, Overseas Education, Online Education Etc.** **DESIGNATION: - Executive Assistant** **EXPERIENCE: - 2-5 Years** **QUALIFICATION: -...