Executive- Drug Regulatory Affairs

**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...

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,...

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...

**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...

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...

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,...

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...

**JOB DESCRIPTION** **ProfileJob Title**Company Secretary and Legal Affairs**Department** **Location / Unit**Sarvodaya Hospital, Sector-8, Faridabad**Position Reports to** **Key Relationship**All doctors, All nurses, All paramedical staff, Guest Relations and all HODs.**Main Objective of the Role**Responsible for ensure that our company complies with...

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...

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...

**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...

**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...

**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...

Job Description Summary **Job Description**: As a Medical Writer, Scientific Affairs - Medical Affairs you will be responsible for the evaluation of clinical data and in the writing/creation of clinical and scientific reports. These documents are used in regulatory submissions to support safety and performance of our products, to help define clinical...

Currently we required Medical writer for leading medical device company location - Nuh, Mewat, Sohna - Skilled in writing, reviewing and editing scientific medical write-ups including medical studies, drug trials, study reports, white papers, summaries and regulatory documents, or marketing medical writing. - Developing scientific content that is...

**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...