145 Row Market Jobs

Job Responsibilities: Development of oral solid dosage forms (tablets, capsules) including IR, MR, and coated products. Handling product development, optimization, and scale-up activities.

1. Senior Manager/Manager - Regulatory Affairs (API - US/EU Focus) Required: 15-20 years (with 5+ in API regulatory leadership) Qualifications: M.Pharm, B.Pharm, or M.Sc. (Chemistry/Organic) Key Responsibilities: Lead API regulatory strategy, including preparation and submission of US DMFs, EU ASMFs/CEPs, and filings for Japan PMDA/KFDA. Oversee team (5-10 members) for pre-approval inspections, audit responses, and post-approval changes/variations. Manage stability programs, OOS/OOT investigations, and QMS compliance per FDA/EMA guidelines. Collaborate with R&D, QA, and manufacturing for regulatory intelligence and gap assessments. Handle agency queries, renewals, and risk assessments for on...

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in acco...

- Compilation & review of AMV, PV data - Preparation of CTD and ACTD dossier modules - Complete dossier preparation as per ROW market, Latam - Handling of regulatory queries - Follow up with client's regulatory - Job allocation to the subordinates

Role & responsibilities 1. The candidate will be responsible for the preparation and review of product registration and renewal dossiers (CTD/ACTD) for various ROW markets. 2. The candidate will be responsible for understanding, interpreting, and implementing regulatory guidelines for different ROW countries. 3. The candidate will be responsible for preparing and renewing registrations, manufacturing licenses, product permissions, WHO-GMP certificates, MSO registrations, and other regulatory documentation required by ROW authorities. 4. The candidate will be responsible for leading the preparation, review, and submission of regulatory documents to relevant health authorities across ROW marke...

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.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Around 4-7 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (small molecules as well as biologicals ...

Prepare/review CTD/eCTD dossiers; manage registrations, renewals & variations; handle regulatory queries; support audits; coordinate with R&D/QA/QC/Production; ensure global compliance; review labeling; maintain regulatory documentation.

Preparation & Compilation of Dossier in ACTD / CTD format as per standard guidelines of the countries Handling of Daily activities of D.R.A. department Review of Technical documents and samples for registration purpose. Preparation of documents as per specific requirement of the countries. Knowledge of legal documents and Authority's Regulatory documents such as NOC, Product Permission, COPP, FSC, Manufacturing licenses, GMP, WHO GMP etc. Responsible for Preparation / Reviewing of :- (i) MSDS (ii) Package Insert/PIL (iii) Drug Master File (IV) RMP Product Artwork checking & approval in regulatory aspects for export and maintain their records. Ability to work productively in a team environmen...

Roles and Responsibilities:- Collect and coordinate information and compile regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. Preparation & compilation of dossier in CTD, ACTD, ECTD & country specific format according to guidelines of countries. Response to query/deficiency/Notice of Deficiency raised by Drug Regulatory Authority or technical representative. Coordination with Quality Control, Quality Assurance and Production department for regulatory documents. Timely compile documents for license renewals, update and re-registrations. Maintain regulatory files/database and chronologies in good order. Establish and ma...

1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timel...

Roles and Responsibilities Develop and execute international business strategies to drive growth in emerging markets, focusing on Africa, Middle East, and South America. Lead a team of international sales professionals to achieve revenue targets through effective channel management and customer engagement. Collaborate with cross-functional teams to identify new business opportunities, develop market entry plans, and negotiate partnerships with key stakeholders. Analyze market trends, competitor activity, and customer needs to inform strategic decisions and optimize international operations. Manage relationships with distributors, agents, and other partners to ensure successful product launch...

Registration and Renewal dossiers in CTD, ACTD & Country Specific format To prepare the dosiers for allotted countries Timely answering the queries EXP in ROW market(Guatemala) B. Pharm, M.Pharm,Science graduate/PG Required Candidate profile Exp as Head of department for ROW-Regulatory affairs Exp in Team handling kindly send resume to hr1@flamingopharma.com,sunil@flamingopharmacom

Job Title: Senior Executive / Manager 2 – Plant Regulatory Affairs Business Unit: R&D1 Regulatory Affairs Job Grade G11B/G11A Location Halol At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Description: Particip...

Regulatory Affairs Executive to ensure our cosmetic products comply with US FDA, EU, and Indian regulations. The role includes handling regulatory documentation and preparing MSDS, COA, and certifications. Required Candidate profile They will support QC/QA with specification & GMP documents, and review artworks as per country guidelines. Strong regulatory knowledge, documentation accuracy, and communication skills are essential.

Responsibilities: * Manage regulatory dossiers from start to finish * Ensure compliance with ROW market requirements * Prepare CTDs and ACTDs for product approvals * Collaborate with cross-functional teams on regulatory strategy

Job Description Sr. Executive, Regulatory Affairs (ROW Markets) Department: Regulatory Affairs (RA ROW) Experience: 4–8 Years Location: Hyderabad Company: Jodas Expoim Pvt. Ltd. Role Summary The RA-ROW Sr. Executive will be responsible for preparing, reviewing, and submitting regulatory dossiers for Rest of World (ROW) markets, ensuring compliance with country-specific regulatory requirements. The role requires strong coordination with cross-functional teams in Manufacturing, QA, QC, R&D, Packaging Development, and SCM to support product registrations, renewals, and post-approval lifecycle management. Key Responsibilities 1. Dossier Preparation & Submission Prepare, compile, and review regul...

Registration and Renewal dossiers in CTD, ACTD & Country Specific format To prepare the dosiers for allotted countries Timely answering the queries EXP in ROW market(Guatemala) B. Pharm, M.Pharm,Science graduate/PG Required Candidate profile Exp as Head of department for ROW-Regulatory affairs Exp in Team handling kindly send resume to hr1@flamingopharma.com,sunil@flamingopharmacom

Candidates having experience in DMF preparation of Semi finished formulations are preferred

Job Title: Executive – Regulatory & Business Continuity Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Description: Preparation of registra...

Responsibilities: CTD/ ACTD Process Validation (PV) BE Study Stability PDR Art work Check BMR/BPR Preparation SMPC Leaflet flit Preparation (Insert) AMV CDP Match Spect COA/MOA Finish Specifications Self-Prepared and Review

Job description Role & responsibilities 1. Candidate will be based at Mumbai and responsible for handling International Business Development for Animal Health Business covering ROW Market. 2. You will be responsible for Promoting Animal Health products to gain maximum market share. 3.You will be responsible for identifying & registering new products , handling imports & logistics & dealing with dealers, distributors & collection of payments. 4. You will out late business across new geographies in ROW Market by strategically shortlisting products/partners and business models 5. You will train field force and business partners on company products for quality representation, and work in the fie...

Role & responsibilities 1. Ensure to aligned the product development and its documentation with R&D and Export Dept. 2. Submission of dossiers to overseas and Indian authorities in time for approvals 3. Submission of all approved documents either for Finished product or API to CQA and QA at various plant 4. Maintain the MIS data for each product pre and post approvals 5. Preparation & Compilation of the product Dossiers of various pharmaceutical formulations for CIS & ROW Market. 6. Review of all technical documents (BMRs, Process Validation, Method of Analysis, Analytical Method validation, Stability, API , FP , PM COAs & DMF etc.) recd. from Factory & follow-ups with related departments fo...

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format preparation. Coordinate with cross-functional teams (QA, QC, Marketing) to obtain necessary documents for dossier compilation. Ensure compliance with regulatory requirements by reviewing documents such as SOPs, protocols, reports, and batch records. Review and compile dossiers according to client specifications and timelines. Maintain accurate records of all activities related to dossier compilation. Desired Candidate Profile 2-4 years of experience in Regulatory Affairs or a related field (B.Pharma / M.Pharma). Strong knowledge of drug regulatory affairs in the Row market (European region). Pro...

Role & responsibilities Identify and analyse regulatory requirements for different countries; assist in product registration. Periodically track worldwide regulatory developments, provide timely alerts on regulatory changes, and ensure adherence to compliance standards. Prepare DMF/dossiers for regulatory submissions (India, Europe, US, Canada, Australia & ROW); handle application filing, tracking status, and liaising with regulatory authorities. Coordinate with internal stakeholders to gather essential technical information for dossier preparation. Assist in Product life cycle management (maintenance, renewal of product registration) & compliance related activities. Handle customer queries ...