131 Dossier Preparation Jobs - Page 6

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 online review, submission with customer / agency & assessment phase Post approval life cycle management i.e. variation, renewal, updated dossier, variation status Interested candidate can share cv on creyesha.macwan@alembic.co.in

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 country sales managers on regulatory requirements. Provide strategic advice to senior management throughout the development of a new product. Manage teams of colleagues involved with the development of new products. Undertake and manage regulatory internal audits .. Review company practices and provide advice on changes to systems. Liaise with, and make presentations to, regulatory authorities. Follow up with marketing team for marketing authorization, registration data and status. Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Experience in Dossier. Preferred candidate profile Qualification required: Graduate in Pharmacy/ Science Post graduate in Pharmacy/ Science Female Candidates Experience required: 2 to 4 years in preparing dossiers for ROW market. Should be experienced in preparing country specific dossiers. Well versed with country specific guidelines. Fluent in communication. Candidate should be living around Andheri or should be comfortable travelling to Andheri (E).

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 guidelines (e.g., ASEAN CTD, GCC guidelines, country-specific checklists). Liaise with local agents, consultants, and regulatory authorities in ROW/Asian regions to facilitate smooth product approvals. Handle query responses and post-submission commitments effectively and within stipulated timelines. Monitor and interpret regulatory requirements and changes in ROW/Asia and communicate their impact on the business. Coordinate with cross-functional teams (RA, QA, QC, Production, R&D, Supply Chain) to collect, review, and verify technical documents for regulatory submissions. Manage and maintain product registration dossiers, variation submissions, renewals, and annual updates. Provide regulatory input during development and technology transfer stages for injectable products. Preferred candidate profile

Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidance's assuring technical congruency and regulatory compliance. US submissions Required Candidate profile Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle. knowledge of CTD /eCTD for submission of dossiers B. Pharm / M. Pharm 5 - 8 Years

DRA Manager Experience- 15 years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit candidate apply on contact ;-9041666549

Gayatri Human Resources Immacule Lifesciences (P) Ltd. (Address. Village Thanthewal, Ropar Road, Nalagarh, Distt. - Solan, (H.P)-174101) Mobile No :- +91-8278729004 We are seeking a detail-oriented and proactive Regulatory Affairs Officer/Executive with hands-on experience in Oral Solid Dosage (OSD) regulatory submissions for international markets including ROW, USFDA, and MHRA . The ideal candidate will be responsible for compiling, reviewing, and submitting high-quality regulatory dossiers and ensuring compliance with the regulatory requirements of various global health authorities. Key Responsibilities: Prepare, compile, review, and submit regulatory dossiers (CTD/eCTD formats) for OSD products for USFDA, MHRA (UK), and various ROW markets . Ensure timely and accurate submission of ANDA , variation filings , renewals , and annual reports . Coordinate with cross-functional teams (R&D, QC, QA, Production, etc.) to gather necessary documentation and technical data required for submissions. Review technical documents , product development reports, validation protocols/reports, stability data, and other regulatory documents for accuracy and compliance. Maintain knowledge of regulatory requirements and guidelines for target markets (US, UK/EU, LATAM, Africa, Southeast Asia, etc.). Handle regulatory queries and deficiency letters from agencies such as USFDA and MHRA, and provide timely and effective responses. Monitor changes in regulatory requirements and assess their impact on product registration and compliance. Maintain and update the regulatory database and track submission timelines and approvals . Support in product lifecycle management and post-approval changes. Liaise with external regulatory consultants, agents, and local partners as needed for market-specific requirements. Required Skills & Competencies: In-depth knowledge of international regulatory requirements and guidelines (ICH, USFDA, MHRA, WHO, etc.). Strong experience with CTD/eCTD dossier compilation and submissions. Expertise in Oral Solid Dosage (OSD) products. Familiarity with submission platforms like ESG (FDA) , MHRA Portal , etc. Good understanding of GMP, GLP, and GDP practices. Excellent documentation , communication , and interpersonal skills . Strong attention to detail , organizational skills, and ability to manage multiple projects. Proficient in MS Office (Word, Excel, PowerPoint). Preferred Qualifications: Prior experience in a Regulatory Affairs role in a pharmaceutical manufacturing company with exposure to regulated and semi-regulated markets. Experience dealing with regulatory authorities and handling regulatory audits is a plus. Knowledge of labeling requirements , CMC documentation , and QbD submissions will be an added advantage. Gayatri Human Resources Immacule Lifesciences (P) Ltd. (Address. Village Thanthewal, Ropar Road, Nalagarh, Distt. - Solan, (H.P)-174101) Mobile No :- +91-8278729004