Drug Regulatory Affairs

Seeking Drug Regulatory Affairs for a Company into Pharma Industry **Key Responsibilities**: - Research and stay updated on regulatory requirements and guidelines - Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings - Review and assess product labeling, packaging, and promotional materials to...

Ensuring compliance with all regulatory requirements - Maintaining regulatory documentation database - Assisting with the preparation and submission of all regulatory reports - Providing accurate reviews of data and reports - Ensuring accurate and timely submissions to regulatory agencies - Advising others on regulatory and compliance matters Pay:...

**Vacancy**: For Regulatory affairs officer **Job description** **Roles and Responsibilities** 2) To check artworks for regulated/ semi regulated countries. 3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & TP 4) Handling of queries pertaining to regulatory submissions from various regulatory...

**Responsibilities** - Support in creating regulatory and quality policy plan as needed internally and externally - Work with internal personnel and external agencies to implement relevant regulatory requirements - Maintain and submit regular follow up documentation to regulatory/ quality agencies and participate in audits as needed - Document review and...

Greetings, We have an excellent opportunity for Regulatory Affairs officer. Location : Malad Experience :1 + year Role: We are seeking a skilled and licensed Regulatory officer to join our team. The products, managing purchase orders, and ensuring proper follow-up procedures. The officer will play a crucial role in maintaining compliance with...

Looking for RA Executive having min 2 years of Experience **Salary**: ₹40,000.00 - ₹50,000.00 per month Schedule: - Day shift **Experience**: - Regulatory Affairs: 2 years (required) Work Location: In person **Speak with the employer** +91 8002870884

**JOB DESCRIPTION OF REGULATORY AFFAIRS** **TOTAL YEARS OF EXPERIENCE**: 2-4 YEARS - Handling dossier, COPP submission and query Handling for South East Asian Country, East Africa, Latin America, Central America, Europe. - In depth knowledge about regulatory requirements for above region - Need to work independently - Need to have knowledge about legal...

Role Description The RA Executive will be responsible for handling regulatory affairs related to the company's products, filing of DMF, Dossier compilation, co-ordination with third party auditors and authorities, and handling the licensing process. - Knowledge of the regulatory environment and laws in India and around the world - Experience in DMF...

**About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

Maintaining regulatory documentation database Coordinate regulatory documentation activities Develop and implement regulatory strategies Ensure compliance with regulations Develop or conduct employee regulatory training Studying scientific and legal documents Pay: ₹300,000.00 - ₹500,000.00 per year Work Location: In person

Regulatory documentation work under supervision of senior Regulatory staff for a Pharma manufacturing and Export company in Navi Mumbai having its various manufacturing locations in India and exporting its products worldwide. **Salary**: From ₹15,000.00 per month **Benefits**: - Provident Fund Schedule: - Day shift Supplemental pay types: - Yearly...

Maintaining regulatory documentation database Ensure compliance with regulations Prepare and file regulatory submissions Develop or conduct employee regulatory training Liaising and negotiating with regulatory authorities Studying scientific and legal documents Undertake and manage regulatory inspections Coordinate compliance committee Pay:...

We are looking for young and enthusiastic minds, who will be responsible for the following roles - 1. Preparation and compilation of CTD and ACTD dossiers for Vietnam, Myanmar and ROW market 2. Review of Process Validation, Analytical Method Validation, Product Development Records, BMR, BPR, Stability data, Certificate of Analysis etc. required for...

**Company Description** RESPONSIBILITIES: **2. **Serve as a point of contact within the Medical Affairs team for external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in assigned therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use. **3....

**Statistics & Decision Sciences **Quantitative Sciences, R&D Operations** **Position Summary The Associate Statistician provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs in Janssen. Activities associated with the role will...

**Job Type - Fresher or Internship level** Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. **Responsibilities**: **1. Assist in Protocol Development**: -...

**Roles & Responsibility**: - filling and maintaining database of invoices ,expenses incured by marketing agentd and country Managers. - Maintaining sales invoiced data. - maintaining and extracting sales data from super stocklist and distrbutors. **Salary**: ₹15,000.00 - ₹18,000.00 per month **Benefits**: - Flexible schedule - Health insurance -...

**Key Responsibilities**: - **Case Management**: - Receive, document, and assess adverse event reports from various sources, including healthcare professionals, consumers, and regulatory authorities. - Ensure accurate and timely data entry of adverse event information into the safety database. - Conduct thorough case investigations and follow-up activities...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...