145 Row Market Jobs - Page 2

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Responsibilities: * Ensure compliance with regulatory requirements throughout product lifecycle. * Lead RA strategy for Row market, overseeing CTD/ECTD submissions.

Key Responsibilities : Application and preparation of COPP, Product Permission, FSC. Maintain updated records of approvals, renewals, and product registrations. Ensure compliance with national and international regulatory guidelines.

Formulation, ROW Market

Job description of Drug Regulatory Affair Company-Ligasure Healthcare Pvt Ltd. Location- Kolkata Position-Drug Regulatory Affair Key Responsibilities: Develop and implement regulatory strategies for assigned products in ROW markets. Provide regulatory guidance during product development, lifecycle management, and market expansion projects. Interpret international regulations and communicate implications to internal stakeholders. Prepare, review, and submit dossiers (CTD/eCTD or country-specific formats) for new registrations, renewals, and variations. Liaise with local affiliates, agents, or distributors for country-specific requirements and submissions. Track and manage submission timelines...

Job Description We are looking for an experienced Regulatory Affairs Manager to manage and oversee regulatory submissions and compliance for Emerging or ROW (Rest of the World) markets . The role requires in-depth knowledge of international registration requirements, dossier preparation, and life-cycle management of pharmaceutical products. Key Responsibilities Manage regulatory submissions, approvals, and renewals for Emerging & ROW markets (Asia, Africa, Latin America, CIS, Middle East, etc.). Prepare, review, and compile CTD / ACTD dossiers for new product registrations. Coordinate with R&D, QA, QC, and Production teams to gather technical data and ensure dossier readiness. Maintain and u...

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparat...

Seeking a Regulatory Affairs professional (5–12 yrs exp, US FDA focus) to manage product approvals, ensure compliance, and liaise with regulatory bodies. B.Pharm/M.Pharm required.

We seek a seasoned Regulatory Affairs Head to lead and drive the global regulatory strategy for our formulation-based pharmaceutical products across Europe and Rest of World (ROW) markets at Evertogen Life Sciences. As the Regulatory Affairs Head, you will play a crucial role in overseeing all regulatory submissions, compliance management, and lifecycle activities to ensure timely product approvals and sustained market access. This role demands a strong understanding of European Medicines Agency (EMA) regulations and Rest of World (ROW) regulatory requirements, coupled with expertise in dossier compilation, eCTD (Electronic Common Technical Document) submissions, and variation submissions. T...

Collate/prepare and file dossiers in a timely and accurate manner for Formulations and API products to get licenses from various targeted markets (Emerging Markets/ROW). Review and regulatory impact analysis of the change control, communication with customer for notification and approval as applicable. Review and regulatory impact analysis of the changes notified by the vendors as per current regulatory requirements (country specific), as desired. Evaluate any changes proposed post-approval. Prepare and file necessary amendments / supplements / annual reports as applicable to ensure regulatory compliance (Post-approval Life Cycle Management). Prepare the checklist for documentation for regul...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

Hiring in Pharma:Pune/Jejuri:1.Assoc. Mgr – Production (10-12 Yrs.13LPA+Travel) 2.Assoc. Mgr –OpEx (6-8 Yrs.OSD,Lean) 3. Sr. Prod. Mgr(15-17 yrs.RoW Exp) 4.Cartonator Oper.(3-5 Yrs.4–4.5LPA)

Role & responsibilities Support regulatory strategy, registration, and lifecycle management for Pharma products in ROW markets. Prepare, review, and submit regulatory dossiers (CTD/eCTD) as per regional guidelines. Coordinate with regulatory agencies, distributors, and affiliates for approvals and query responses. Maintain regulatory documents, product information, and ensure compliance with health authority requirements. Monitor regulatory updates for ROW markets and share impact with stakeholders. Manage post-approval submissions including variations, renewals, and compliance updates. Work with cross-functional teams (R&D, QA, Supply Chain, Commercial) on regulatory matters Preferred candi...

Role & responsibilities Support regulatory strategy, registration, and lifecycle management for Pharma products in ROW markets. Prepare, review, and submit regulatory dossiers (CTD/eCTD) as per regional guidelines. Coordinate with regulatory agencies, distributors, and affiliates for approvals and query responses. Maintain regulatory documents, product information, and ensure compliance with health authority requirements. Monitor regulatory updates for ROW markets and share impact with stakeholders. Manage post-approval submissions including variations, renewals, and compliance updates. Work with cross-functional teams (R&D, QA, Supply Chain, Commercial) on regulatory matters Preferred candi...

Dear Candidates, We have an opportunity with clinical trial development and CRO related assets and capabilities from an existing ACRO/SMO organization that is based in Chennai. We have over 10 years of experience running clinical trials as part of the global Group. Position Overview The Head of Regulatory Affairs is responsible for providing strategic leadership, oversight, and execution of all regulatory activities within the organization. This role ensures that the CRO maintains compliance with global regulatory standards (FDA, EMA, MHRA, CDSCO, etc.) and supports clients in achieving regulatory milestones efficiently and compliantly. The position requires strong leadership, scientific exp...

Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories Private Limited, MSN House, D.No: 2-91/10 & 11, White Fields,Kondapur, Hyderabad on Sunday 16-11-2025 Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 03 to 12 years of experience in FML Regulatory Affairs Job Title : Executive / Senior Executive / Junior Manager / Assistant Manager / Deputy Manager Experience : 03 to 12 years in FML RA field Education: B Pharm \ M Pharm Department : Regulatory Affairs - FML Roles & Responsibilities : Collect documents from various departments to prepare regulatory submissions. Prepare regul...

Role & responsibilities 1. Managing Formulation development of New or existing formulations for ROW/ Regulated market as per business requirements including Oral Solids (Tablet & Capsules) IR tablets, Sustained release tablets, extended release tablets, Bilayer tablets, Capsule etc. & External preparations like Gels, Pastes, Creams, Ointments etc. 2. Leading team of FDL Officers, Technicians & workers by proper FDL planning and execution of each Project including creation of theoretical formulation, Pre-formulation studies, Trials, Optimization trials, Stability, Scale-up batches etc. 3. Conducting intellectual searches for technical information through a variety of resources, including the ...

DOSSIER PREPARATION, ACTD, CTD, ROW, ASEAN, DOCUMENTS REVIEW, MAINTAIN DATABASE

We are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma formulations.

Job Title: Regulatory Affairs Head / Manager API Division Department: Regulatory Affairs Industry: Pharmaceuticals Active Pharmaceutical Ingredients (API) Location: Andheri East Experience Required: 815 Years (API Regulatory Affairs) Qualification: M.Pharm / B.Pharm / M.Sc (Chemistry / Pharmaceutical Sciences) Salary Up to 1Lakhs per Month Job Purpose: To lead and manage the Regulatory Affairs department for API products, ensuring compliance with global regulatory requirements and facilitating product registrations, dossier submissions, and approvals across domestic and international markets. Key Responsibilities: Regulatory Strategy & Compliance: Develop and implement regulatory strategies ...

Job Title: Regulatory Affairs Head / Manager API Division Department: Regulatory Affairs Industry: Pharmaceuticals Active Pharmaceutical Ingredients (API) Location: Andheri East Experience Required: 815 Years (API Regulatory Affairs) Qualification: M.Pharm / B.Pharm / M.Sc (Chemistry / Pharmaceutical Sciences) Salary Up to 1Lakhs per Month Job Purpose: To lead and manage the Regulatory Affairs department for API products, ensuring compliance with global regulatory requirements and facilitating product registrations, dossier submissions, and approvals across domestic and international markets. Key Responsibilities: Regulatory Strategy & Compliance: Develop and implement regulatory strategies ...

Job Title: Executive / Senior Executive Regulatory Affairs (API) Location: Noida or Hyderabad, India Job Type: Full-Time Role Overview: We are seeking a motivated and detail-oriented Regulatory Affairs Professional to join our API regulatory team. The candidate will be responsible for preparing and reviewing eCTD sections of regulatory submissions (ASMF/CEP) and data packages for European markets, ensuring compliance with international regulatory standards. Key Responsibilities: Coordinate with cross-functional departments to arrange required technical data for ASMF/CEP and technical package preparation . Review quality and manufacturing data for APIs for regulatory adequacy as per relevant ...

Dear All, We have arranged a Walk-In Interview for Regulatory Affairs (Formulations) - Executive / Sr. Executive where we are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! (Venue details are given at the end). Experience in Regulatory Affairs is must. Role & responsibilities Preparation of CTD dossiers for Regulated manket [EU/UK/TGA] or ROW market - Asia & Africa market. Experience in handling modules 1 to 5 or atleast 4 & 5 is mandatory. Co-ordination with Plant, R&D & ADL to collect inputs required for Regulatory submission. Variation filling. Timely achievement of monthly plan. Interpretation and timely query response. Education - B.Pha...

Role & responsibilities 1. DMF Complications 2. Query response preparations 3. life cycle management 4. Marketing/ Customer Communications 5. Quality Documents/ Submissions review 6. Change Control Management/ RIMS Management

Responsibilities: * Manage regulatory compliance for Row Market products using CTD format under ICH guidelines. * Ensure timely submission of dossiers and variations in accordance with regulations.