162 Dossier Jobs - Page 7

Preparation & Review of dossier in CTD, ACTD, ETCD format Preparation of dossiers of stability Data, Analytical method validation Preparing the SPC/SMPC as per country guidelines Preparation and Reviewing of documents COA as per the country guideline

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

We have urgent requirement for : Profile : Drug Regulatory Affairs Executive Experience : 2 years to 8 years Location : Nalagarh Skills Required : CTD , ACTD, Dossier Prepration, ACTD, Row Market, Ukraine, Malaysia, Thailand , Mexico etc Interested Candidate can send resume at hr2@theonpharma.com or contact @ 7717304694

Job Title: Senior Regulatory Executive RoW Market ( LATAM Specially) Location: Ahmedabad Experience: 5–7 years in Regulatory Affairs (RoW markets) Qualification: B.Pharm / M.Pharm / Life Sciences Key Responsibilities: Prepare & review CTD/eCTD/non-CTD dossiers for new registrations, renewals, and variations. Coordinate with agents/distributors for submissions and query responses. Track timelines and ensure compliance with regulatory guidelines (LATAM, Africa, CIS, Asia). Manage product lifecycle: variations, renewals, packaging/labelling updates. Maintain regulatory databases and trackers. Key Skills: Strong knowledge of RoW regulatory requirements & dossier formats. Experience with LATAM co...

Minimum of 2-5 years of experience in the pharmaceutical industry and should be able to independently compile ACTD, CTD Dossiers and Country-specific Dossiers for international markets, Adept at query resolution etc. Required Candidate profile Qualifications: A BPharm/ M Pharm with knowledge and experience of international regulatory affairs in Pharmaceutical Industry.

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Executive / Sr. Executive based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 4 - 8 yrs. with dossier filling experience in Europe & South Africa Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skills. Job Description: Review of product initiation form /extension form Review of technology transfer documents Dossier compilation / periodic updates in dossier checklist CTD/NeeS/eCTD Submission & correspondence with agency / customer CoPP Dossier onl...

Position: Regulatory Affairs Executive Location: Andheri (E) Role & responsibilities Ensure that the company's products comply with the regulations of the regions where they are distributed. Keep up to date with national and international legislation, guidelines and customer practices. Prepare dossiers, documents and samples as per requirement of markets for participation in tenders. Collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats. Monitor and set timelines for registrations variations and renewal approvals and submissions. Write clear, accessible product labels and patient information leaflets. Advise c...

Role & responsibilities We are seeking an experienced and detail-oriented Executive Officer Drug Regulatory Affairs with a strong background in injectable dosage forms to join our regulatory team. The ideal candidate will be responsible for regulatory submissions, dossier compilation, and lifecycle management of products specifically targeting the Rest of the World (ROW) markets, with a focus on Asia (e.g., ASEAN, Middle East, South Asia). Key Responsibilities: Prepare, compile, review, and submit high-quality regulatory dossiers (CTD/eCTD formats) for injectable formulations for registration in ROW/Asian countries. Ensure that all submissions comply with country-specific regulatory guidelin...

Role & responsibilities Reviewing of documents received from Project Managers and then preparing and filling of dossiers for BE NOC/CT NOC/GCT/biosimilar Clinical trial as per New Drugs and Clinical trials rules 2019. Reviewing, preparing and filling of dossiers seeking Import License for Investigational Products for bio-studies/Clinical Trials for DCG(I) submission as per New Drugs and Clinical trials rules 2019. Export of biological samples of biostudies/Clinical Trials done in India for DCGI approval. Reviewing, preparing and filling of dossiers seeking approval from ICMR, New Delhi for import of biological samples for analysis purpose Reviewing, preparing and filling of dossiers for gett...

Hi, We have opening for the position of API regulatory affairs department for API Manufacturing industry. Role & responsibilities 1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries 2. Submission of DMF amendments and variation filings to implement the post approval changes 3. Evaluation of change controls and perform regulatory assessment based on submitted DMF 4. Co-ordinated with cross functional team such as QA, QC,production, ADL and R&D and review of documents received for registration purpose. 5. To Maintain regulatory database by following best regulatory practices 6. To prepare action plan for De...

1. Should have a good knowledge in Regulatory Affair policies 2. Good communication and interpersonal skills. 3. Formulating and implementing various report formats based on business understanding. 4. Regular communicating with International clients Required Candidate profile Should have worked in Pharmaceutical / Veterinary Industry. Experience in Europe / Canada preferred. If interested please call at: 7742408300/7742408200 & mail resume at: lksaddiassociate@yahoo.co.in Perks and benefits Salary will not be constraint for right candidate.