Coordinator Regulatory Submission

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:...

**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...

Mumbai, Vile Parle East - Share Position: Regulatory Executive Job Location: Vile Parle Mumbai: Maharashtra Eligibility: M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries FDA: Registration and Post-registration activities in...

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team. Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier collation...

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...

**ob description** **Urgently Required Regulatory Affair for Formulation** **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 & 3rd party manufacturing 4) Handling of queries pertaining to regulatory...

**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...

About the role: Reporting to the Head of Regulatory Affairs, you will be a key member of the team which is responsible for providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments. Our Regulatory Affairs Department has an ethos of...

**Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...

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:...

**Job Title Regulatory Reporting** **Location - Mumbai, India** **Role Description** Loan Operations India, operating from a Centralized location in Mumbai supports lending products across various business lines in the Corporate & Investment Bank, spread across India. **What we’ll offer you** As part of our flexible scheme, here are just some of the...

MANAGER-REGULATORY AFFAIRS INTERNATIONAL Preparation and reviewing of CTD and ACTD dossier.- Coordination with Plant and R&D to collect inputs required for Regulatory Submission.- Co-ordination with plant for Regulatory compliances.- Timely achievement of monthly plan & timely query response.- Gap Analysis/Updation of Master data.- Review of Change...

**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...

Dossier preparation (both ACTD and CTD) and Submission for countries Technical review of documents Co-ordinate with QC, QA departments in plant for that documents and samples required for regulatory submissions. Prepared samples and working standards for courier to clients for registration purpose. Artwork review. co-ordination with client and handle...

**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...

When our values align, there's no limit to what we can achieve.   Senior Regulatory Affairs Associate Around 4-8 y ears of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends,...

When our values align, there's no limit to what we can achieve.   Senior Regulatory Affairs Associate Around 4-8 y ears of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional...

**EXECUTIVE DRUG REGULATORY AFFAIRS (PHARMA-FORMULATIONS)** Job Responsibility - Preparation and submission of dossiers as per countries assigned. - To handle inquiries from Regulatory Authorities related to company and product registration. - Submission of Registration Dossiers in EU, Semi-Regulatory and Emerging market. - FDA related work - Application...