98 Row Market Jobs

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4.0 - 8.0 years

6 - 8 Lacs

navi mumbai

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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...

Posted 22 hours ago

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3.0 - 5.0 years

3 - 5 Lacs

hyderabad

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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

Posted 23 hours ago

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2.0 - 5.0 years

3 - 4 Lacs

ghaziabad

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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.

Posted 3 days ago

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12.0 - 18.0 years

25 - 40 Lacs

ahmedabad

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1. Work closely with President Business Operations Emerging Markets on all business related issues for all the regions. 2. Analysis on monthly MIS 3. Order management and budgets 4. Follow-up with supply chain on orders 5. Shipment cost analysis Air/ship 6. Inventory Management 7. Quarterly forecast for sales & EBIDTA 8. Month on month business review for each stakeholder. 9. Subsidiary management 10. Coordination with finance on collection management. 11. To support Regional Heads with Business Operations as and when needed. 12. Work closely with President Emerging Markets on issues related to - Regulatory - Project Management - Portfolio Management - Tech Transfer 13. Closely work with Hea...

Posted 3 days ago

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5.0 - 9.0 years

6 - 8 Lacs

navi mumbai

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Role & responsibilities Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain well-organized records of submissions, ...

Posted 5 days ago

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10.0 - 15.0 years

4 - 9 Lacs

mumbai, chennai

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Seeking an experienced Manager/Sr. Manager – Exports (Pharma) with strong ROW market expertise and a proven track record in international business development and regulatory compliance

Posted 1 week ago

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4.0 - 8.0 years

0 - 0 Lacs

hyderabad

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Unique Biotech Ltd. is looking for an experienced and dynamic International Business Development Executive to join our growing Sales team . Position: International Business Development Executive Department: Business Development International (ROW Markets) Experience: 4–8 years Location: Hyderabad Key Responsibilities: Develop and manage international business opportunities in ROW (Rest of the World) markets for API and Bulk products. Identify, approach, and establish relationships with potential global clients and distributors. Achieve sales targets and ensure consistent revenue growth. Coordinate with internal teams for pricing, documentation, and regulatory support. Conduct market research...

Posted 1 week ago

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15.0 - 24.0 years

15 - 20 Lacs

mumbai, paonta sahib

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Role & responsibilities Setting up International Business set-up at Tirupati Group. Generate new business from International clients in P2P / Contract manufacturing model from ROW Countries. Explore markets with different business Strategies, Negotiate Commercial business Terms & Executes agreements and post deal management. To handle and coordinate with existing clients and get new products from them. Find out right business partner (Globally) for right products & registration process , To ensure coordination between clients & internal department if need and close the enquiry with proper actions like offer /samples/data etc. To work on a growth strategy focusing customer satisfaction and fi...

Posted 2 weeks ago

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8.0 - 12.0 years

11 - 15 Lacs

navi mumbai

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Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and there timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW a...

Posted 2 weeks ago

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8.0 - 12.0 years

15 - 25 Lacs

mumbai suburban

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Executive / Sr. Executive Level: • Assistant Manager & Above: Position: Export (International Business) Business Development Team Target Market: Rest of the World (ROW) candidates with strong experience in Oral Solid Dosage (OSD) products across the Middle East, Southeast Asia, LATAM, Africa, and CIS regions are preferred. Preferred Profile: • Science graduates with an MBA in International Business • Maximum age: 45 years • Energetic, proactive individuals who are open to traveling for business requirements What We’re Looking For: Expertise in Pharma ROW Markets & Global Expansion Strong business development & sales acumen Knowledge of regulatory processes & international client handling Exc...

Posted 2 weeks ago

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9.0 - 10.0 years

7 - 9 Lacs

gurugram

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Roles and Responsibilities (5 days working) Dossier (CTD, ACTD & Country Specific Format) review for Latam, ASEAN, CIS & African countries. Collaborate with various departments within the organization, such as Plant (QA, QC, Production, Packing & Purchase) and R&D, to gather the necessary inputs for regulatory submissions. Compilation and timely submission of Dossiers to the respective regulatory authorities in the assigned countries. Planning, monitoring, review, strategy & delegation of the below mentioned activities for Countries: New Product Registration, Re-Registration, Retention, Tender. Handling of queries from various regulatory authorities/consultants. Post Approval Changes GMP (Co...

Posted 2 weeks ago

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5.0 - 10.0 years

3 - 8 Lacs

bengaluru

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Role & responsibilities Dossier and regulatory document preparation Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations Visiting FDA office for follow ups on applications Preferred candidate profile Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions. Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats. Strong documentation management, including version control,...

Posted 2 weeks ago

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7.0 - 12.0 years

5 - 9 Lacs

ahmedabad

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Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats. Responsible for final review of dossier before submission. Reviewing artwork for products as per relevant regulatory authority requirements. Coordination with F&D, QA, QC & Store for documentation In-depth knowledge of pharmaceutical documentation & regulatory guidelines. To coordinate with technical team for documents required for dossier. Country Experience Preferred: CIS, LATAM Dosage Form Experience: Soild Oral + Injectable Preferred candidate profile

Posted 2 weeks ago

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10.0 - 20.0 years

20 - 35 Lacs

bengaluru

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Urgent Hiring for Business Development Manager Exp – 10 to 18 Years in API/ Pharma • Addressing customer query • Getting new business links through different social platforms • Meeting customers • BDM area of pharma for Europe and ROW market Required Candidate profile • Sending quotes, discussion, negotiations • Attending BD conferences Location – Bilekahalli, Bangalore ltd Pharmaceutical Company Company Profile – Pharmaceutical Manufacturing Industry Perks and benefits PF, Bonus, leaves, Graduatee, Facilities Available

Posted 2 weeks ago

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3.0 - 8.0 years

3 - 8 Lacs

hyderabad

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Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 18-10-2025. Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 03 to 08 years of experience in FML Regulatory Affairs Job Title : Executive / Senior Executive / Junior Manager Experience : 03 to 08 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 regulatory submissions to relevant authorities. Prepare amendments, updates, and re...

Posted 3 weeks ago

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10.0 - 12.0 years

7 - 9 Lacs

gurugram

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Roles and Responsibilities (5 days working) Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets. Handle team responsibilities related to dossier compilation, review, and approval. Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization. Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines. Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation. Desired Candidate Profile M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs. Strong understanding...

Posted 3 weeks ago

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4.0 - 8.0 years

0 - 1 Lacs

bidar

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scientistsDepartment: Formulation Research and Development Duties and Responsibilities: The responsibilities of the Scientific Leader include Prepare and maintain a project tracker with date and schedule and scientists' activities Serve as the point of contact for RM procurement tracking directly with Purchase team, experiment planning, executions and updates in the India laboratory. Provide regular updates to Head of the Dept. on project technical status. Manage work schedule and appropriate human resouresourcesrce based on prioritized experiments with Head of Dept. Work with the scientific and admin team to track ordering and inventory status and maintain lab to maximum functioning efficie...

Posted 3 weeks ago

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3.0 - 8.0 years

4 - 7 Lacs

mumbai

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Regulatory & Licensing Prepare and manage applications for WHO certification, manufacturing & wholesale licenses, renewals, FOSCOS, FDA, and other statutory approvals. Handle CBN export NOCs, biodiversity returns, and related compliance filings. Coordinate with FDA officials (domestic & overseas) during licensing, audits, and certifications. Maintain compliance with cGMP, pharmacopoeial & non-pharmacopoeial standards, and GS1 barcode implementation. Documentation & Dossiers Oversee dossier preparation, submission, and re-registrations for international and domestic markets. Prepare documentation for product registrations, government tenders, and patent projects. Review artwork, promotional m...

Posted 3 weeks ago

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3.0 - 8.0 years

4 - 7 Lacs

mumbai

Work from Office

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

Posted 3 weeks ago

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3.0 - 7.0 years

3 - 6 Lacs

panchkula

Work from Office

Role & responsibilities Job Summary: We are looking for a skilled and motivated Senior Executive Drug Regulatory Affairs to support the registration and maintenance of injectable pharmaceutical products across ROW (Rest of the World) markets . The ideal candidate will have experience in compiling and submitting dossiers in accordance with country-specific regulatory guidelines, and will be responsible for handling end-to-end regulatory activities for injectable formulations in semi-regulated and emerging markets. Key Responsibilities: Prepare, compile, review, and submit high-quality regulatory dossiers (CTD/non-CTD formats) for injectable products in ROW markets (e.g., Latin America, Africa...

Posted 4 weeks ago

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4.0 - 9.0 years

4 - 9 Lacs

hyderabad

Work from Office

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...

Posted 1 month ago

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3.0 - 8.0 years

4 - 7 Lacs

mumbai

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Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

Posted 1 month ago

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2.0 - 5.0 years

3 - 5 Lacs

vadodara

Work from Office

Role & responsibilities Responsible for finding opportunity for cost reduction. Evaluation of low cost API/RM, taking lab trials and documentation thereof for solid oral products. The candidate is responsible for the scale up and technology transfer at plant scale for identified cost reduction products. Should prepare technology transfer documents and support the filing of the product. Should handle the regulatory queries and support the product launching.

Posted 1 month ago

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5.0 - 10.0 years

7 - 11 Lacs

ahmedabad

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- Looking for RA Deputy Manager - for US Market and RA - Asst. Manager - for ROW Market - Only from Pharmceutical Industry

Posted 1 month ago

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3.0 - 6.0 years

4 - 8 Lacs

bengaluru

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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.

Posted 1 month ago

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