98 Row Market Jobs - Page 4

Role & responsibilities - Preparing Dossiers for registration of products in various ROW markets - Knowledge of CTD format is mandatory Preferred profile Qualification: B. Pharm and M. Pharm Experience: 2 years Salary: 20,000 to 40,000 per month Health insurance Accidental insurance Annual bonus

We are looking for Right of Way (ROW) and Lead land acquisition processes for high voltage transmission projects. Handle negotiations, legal documentation, govt. clearances, and stakeholder management to ensure smooth and timely project execution.

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other re...

Role & responsibilities To review and understand technology of product from R&D scientist and coordinate, plan activities with all concerns personnel/ dept. for successful transfer of the products, Monitor tech transfer at site and update documents. To review and understand technology of product from CRO and coordinate, plan activities with all concerns personnel/ dept. for successful transfer of the products, monitor tech transfer at site and update documents. To resolve manufacturing issues/trouble shooting batches at manufacturing sites for the products which are commercialized. Monitoring of redeveloped formulations for quality improvement at manufacturing site. To develop new products a...

Role & responsibilities : Lead Regulatory Affairs department. Should be well versed with submission of Document in CTD/ACTD Format for Regulatory & ROW Market. Should be able to handle team. Preferred candidate profile Reputed Pharma background.

Role & responsibilities 1. Preparation of DMFs for regulated (US, EU) & ROW markets. 2. Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs. 3. Preparation of response to deficiencies from regulatory authorities & customers. 4. Review of the data for DMF preparation received from mfg. site and R&D and ensuring required corrections. 5. Coordination with cross functional teams for data / documents. Review of the DMFs & other submissions prepared by the team. Preferred candidate profile 1. Candidate should be M.Sc. Chemistry with 6-8 years experience OR B.Sc. - Chemistry with 8 years plus relevant work experience in a reputed pharma industry, preferably i...

We are seeking an experienced Regulatory Affairs professional to support and manage the regulatory lifecycle of oral solid dosage (OSD) products across key global markets, including the EU, USA, and RoW.

Roles and Responsibility : To review and arrange required documents to corporate RA for dossiers, query response. To review artwork in artwork management system. R apply product permission, NOC for all manufactured product.R

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

Role & responsibilities Responsible for driving Business development for all ROW and Institutional tender business with end-to-end tender management responsibilities Identify collaboration opportunities, Analysing markets and appointing distributers in the assigned territory Tender Participation in UNICEF/PAHO/WHO/IDA and other institutional agencies Tender management- tender preparation / documentation accuracy / timely submission of EOIs, RFPs and RFQ’s. Coordination with Alliance Management/ Regulatory / IP/ production teams for supply and documentation related needs Stock planning and inventory management in co-ordination with internal teams Ensuring OTIF (on time in full) delivery and d...

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representat...

Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background

Looking for International Business / Sales / BD / EXPORT Manager / Sr Manager for PHARMACEUTICALS EXPORTS. (B2B) Person will be responsible for Export / International Marketing / Sales for Pharma Formulation for ROW Markets. Various Countries Location-Pune Corporate Office (F.C. ROAD). This is a Office Based Job (Pune), Profile : Find distributor for MEDICINES in various countries Study EXPORT DATA , TRADE LEADS , B2B SITES Co-ordination with client and factory for timely delivery of goods. Sales & Marketing includes implementation of planned activity to generate business and to meet the sales targets. The person should be having experience of 8-12 years in a reputed pharmaceutical formulati...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

UpMan Placements is inviting applications for an exciting career opportunity with one of our esteemed clients from the Pharmaceuticals industry. Role : Senior Manager RA Location : Nagpur / Mumbai Reporting To : Director BD Role Requirement: Regular interaction and close co-operation with R&D, BD, Production and Logistics Responsible for the dossier filling & query responses of EU, Brazil, Canada & Row market Role Responsibilities: Develop and execute regulatory strategies to ensure timely product approvals. Preparation, review & submission of ECTD/CTD dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products Preparation, review &...

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

We are hiring an International Regulatory Affairs Executive/Manager with expertise in regulatory documentation, CTD dossiers & query handling. Immediate joiners preferred. Candidates with 1+ year experience may also apply. Join our growing team!

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

Role & responsibilities 1. Preparation of Drug Master File for US, EU and Row countries according to year plan. 2. Preparation and submission of Annual Reports, Amendments and updates to filed DMFs. 3. Preparation and Submission of responses to queries from customer and regulatory authorities. 4. Preparation of Technical information package (TIP) based on customer requirement. 5. Adequacy review of documents required for Drug Master File & TIP preparation like BMR, process validation reports etc. 6. Coordination with R&D, Quality Control and Quality Assurance to collect required documents. 7. Evaluation of impact of changes to the submitted DMF’s. Preferred candidate profile Only API - Indus...

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...

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...

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 pr...