74 Row Market Jobs

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.

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 timely entries of submissions / dispatches Qualifications :- A bachelors degree in B. Pharma Experienced with 1 year Should apply. Excellent communication skills Should be aware about Microsoft office [word / Excel/ PPT] - Good inData management Contact No- 8810226562

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other domestic markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 4 years of exp in Formulation OSD 2. Willing to work in Chennai 3.Strong expertise in EU, EMA, MHRA & other international regulatory framework 4. Exposure in domestic regulatory market

Role & responsibilities Develop and execute comprehensive international marketing strategies to drive business growth across diverse global markets, with a focus on Southeast Asia, SAARC regions and ROW countries. Lead and manage regional marketing operations, including P&L responsibility, revenue maximization, and profitability across multiple countries. Identify and capitalize on new international market opportunities through strategic partnerships, business development, and go-to-market initiatives. Oversee product launches and power brand marketing programs tailored to various international markets, ensuring alignment with local regulations and customer needs. Build and maintain strong relationships with key stakeholders, including customers, distributors, regulatory bodies, and government entities, to facilitate market access and business expansion. Conduct market analysis and competitive intelligence to inform marketing plans, pricing strategies, and promotional activities internationally. Supervise cross-functional teams and lead collaboration with sales, regulatory, and supply chain functions to support business objectives. Drive customer engagement initiatives and develop brand advocacy programs targeted at enhancing market share and product visibility in international markets. Ensure compliance with international quality certifications and regulatory requirements, liaising with consultants and government agencies as needed. Monitor marketing performance metrics and financial targets, providing regular reports and insights to senior management to guide strategic decision-making.

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for new registrations, renewals, and variations. • Ensure dossiers and query responses are complete and compliant. • Coordinate with plants for registration samples and related documentation. Stakeholder Collaboration: • Work with internal teams and external partners to gather and finalize technical documents. Regulatory Operations Oversight: • Compile and submit responses to MOH/partner queries on time. • Track regulatory submissions as per calendar. • Oversee renewals of FDA licenses, WHO GMP, COPPs, etc. Training & Regulatory Intelligence: • Conduct training on updated guidelines. • Share critical regulatory updates with teams. Documentation & Reporting: • Review technical and administrative dossier sections. • Maintain monthly regulatory status reports. • Coordinate site registrations and pre-audit activities. Leadership & Team Development: • Guide the RA team for efficiency and compliance. • Promote process improvements and regulatory best practices. • Handle additional tasks under the RA function. neetij@selectsourceintl.com

Regulatory Affairs Management- Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. Provides regulatory input on procedural and documentation requirements as defined by Health Authorities such as Indian regulatory authority, Emerging markets and ROW countries. Review of documents (e.g. RCGM-PCS, CTA, MAA, PAC, response documents, study protocols, regulatory maintenance documents, PSURs, etc.). Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions. Liaises closely with cross-functional members with aligned product responsibilities. Develops, completes and maintains submission delivery plans, submission content plans, and proactively provides status updates of the ongoing projects within the organization. Coordinates the input, maintenance and revision in the project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to function head. Supports operational team and Project team w.r.t to regulatory requirements. Provides coaching, mentoring and knowledge sharing within the team. Contributes to process improvement. Minimum Requirements Education and Experience Relevant University Degree in Science or related field Minimum 10-16 years of relevant Regulatory experience within the biopharmaceutical industry, including experience in CTA, MAA, PAC and ROW markets for Biological and Biosimilar products and general knowledge of drug development Good knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams. Preferred Experience Regulatory affairs experience across a broad range of markets. Having experience in Regulatory information management system Handled regulatory deliverables at the project level Experience of working with people from locations outside of India, for Emerging and ROW markets. Skills and Capabilities Excellent English written and verbal communication skills Cultural awareness Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions Proficiency with common project management (e.g., MS Project) and document management tools Ability to work independently and as part of a team Influencing and collaborator management skills Ability to analyse problems and recommend actions Continuous Improvement and knowledge sharing focused Operations/Manufacturing organisation (CMC post approval) Marketing Companies/Local affiliates Reporting Relationship Direct Reports – 2-4

Role & responsibilities Regulatory Strategy Development : Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions. Identify regulatory pathways for new product launches and lifecycle management of existing products. Regulatory Submissions and Approvals : Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for injectables across multiple jurisdictions (e.g., Africa, CIS, LATAM). Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines. Compliance Management : Ensure that all pharmaceutical products (particularly injectables) comply with regulatory requirements in target markets across ROW. Review product labeling, packaging, and advertising materials to ensure compliance with local regulatory guidelines. Manage post-market surveillance requirements, including reporting adverse events (AEs), product recalls, or any regulatory non-compliance in the region. Cross-functional Collaboration : Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle. Provide regulatory input and support during the product development phase, particularly for injectables, which often require more complex regulatory scrutiny. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements. Regulatory Intelligence : Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice), GxP, and other relevant policies across various countries in ROW. Act as the internal subject matter expert on regulatory issues related to injectables in ROW markets. Monitor competitor activities and regulatory trends in the ROW regions, particularly for injectables. Regulatory Affairs Leadership : Lead and manage a team of regulatory professionals across the ROW regions, guiding their work in regulatory submissions and compliance activities. Provide mentoring and training to team members to enhance their regulatory knowledge and skills, particularly in the injectables segment. Risk Management & Problem Solving : Identify and mitigate regulatory risks related to the approval process for injectables in target regions. Address regulatory challenges or delays and take proactive steps to resolve issues, including negotiating with health authorities or addressing deficiencies in submissions. Regulatory Advocacy and Relationship Management : Build and maintain strong relationships with key regulatory authorities in various ROW regions, including ministries of health, regulatory bodies, and industry associations. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations and injectables. Documentation & Reporting : Maintain accurate and comprehensive regulatory files and documentation for products, especially injectables, in compliance with regional regulations. Provide regular updates to senior management on regulatory milestones, challenges, and market access status. Preferred candidate profile Must have experience into injectables dosage forms.

Responsibilities: * Exp on procedure of application of new Drug * Manage COPPs, GMP, GLP compliance & SUGAM portal maintenance * Oversee license renewals, dossier reviews & NIB submissions * Trademark License & Coordinate with Drug Control Authority

ROW Market Expansion, CTD/eCTD Dossiers, Registrations, Renewals, Variations, CDSCO Compliance & Audits: Regulatory Audits, Inspections, Artwork Compliance, Promotional Materials, Risk Mitagation Mail ID- mrinmay.d@ligasure.com

JD's : Regulatory Strategy: ROW Market Expansion,CTD/eCTD Dossiers,Registrations,Renewals,Variations,CDSCO Compliance & Audits: Regulatory Audits,Inspections,Artwork Compliance,Promotional Materials,Risk Mitigation Mail-mrinmay.d@ligasure.com Annual bonus

Hands on experience in dossier preparation and gap assessments. Strong command over ICH guidelines, CMC documentation, and market specific requirements. Skilled in preparing responses to client and authority queries. Proven ability to handle CTD/ACTD modules 1, 2 & 3. Familiarity with ROW regulatory expectation.

Responsibilities: * Oversee regulatory affairs processes * Manage dossier submissions & preparations * Ensure compliance with the Latam market requirements * Lead row market strategies * Client query resolution. * Artwork review.

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.

"Opportunity for M.Pharm professionals in Formulation Development (R&D) to work on sterile and non-sterile dosage forms (ANDA/ROW/US-OTC) with leading pharmaceutical projects in Mumbai.

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 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives.

Role & responsibilities 1. To ensure that all required information is included in the regulatory filing. 2. To collect the documents require for dossier preparation. 3.To evaluate the country wise requirements for dossier preparation as per checklist. And compile a draft dossier as per requirements and in the format provided by the authority of the country. 4.To co-ordinate with Artwork, Purchase, QC, QA, R&D, Packaging, Licensing Department for necessary documents/data. Prepare documents for courier purpose and send the courier. 5. Keep a track of the courier to check delivery on time. Providing comments on the product, preparing and submitting a regulatory application, and working with other team members to help with the process. Preferred candidate profile : Reputed Pharma background only

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 accordance with the regulatory and code of conduct requirements; Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile Qualification: B. Pharm and M. Pharm Experience: Minimum 5 years in ROW market for Formulation Dossier preparation and submission Perks and benefits Salary: 40,000 to 70,000 per month Mediclaim Bonus

Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software and resources write clear, accessible product labels and patient information leaflets plan and develop product trials and interpret trial data advise scientists and manufacturers on regulatory requirements provide strategic advice to senior management throughout the development of a new product project manage teams of colleagues involved with the development of new products oversee product trials and interpret trail data undertake and manage regulatory inspections review company practices and provide advice on changes to systems liaise with, and make presentations to, regulatory authorities negotiate with regulatory authorities for marketing authorisation take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities Preferred candidate profile

Role & responsibilities Dossier Preparation and Submission: 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, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Markets - Regulated (EU/UK/Aus) or ROW (Asia & Africa) Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume on vaibhavi.b@titanpharma.com or -contact 022 - 6785 7000 (Ext 725). If you have good references you can share on above details. Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd

Job Description: Regulatory Affairs Executive (ROW Markets) Industry: Pharmaceuticals Experience: 3-5 Years Loaction: Chennai Key Responsibilities: Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets. Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers. Document Review: Review BMR, specifications, COA, MOA, and technical documents for compliance. Artwork Coordination: Ensure accuracy in labeling & packaging artwork with regulatory standards. FDA Compliance: Maintain records for FDA licenses (Product Permission, CoPP, FSC) . Legal Documentation: Track notarized & legalized documents for international submissions. Eligibility & Requirements: Education: B.Pharm / M.Pharm (Pharmacy graduates preferred). Experience: 3-5 years in regulatory affairs, dossier submissions, or pharma compliance . Skills: Strong knowledge of ACTD/CTD dossier formats . Familiarity with FDA, EMA, and ROW market regulations . Attention to detail in documentation & compliance checks . Proficient in regulatory tracking systems & MS Office .

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Preferred candidate profile Hiring for API & Formulation background candidates for Regulatory Affairs Team Good Communication Skill in English

Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 06-09-2025. Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 02 to 07 years of experience in FML Regulatory Affairs Job Title : Executive / Senior Executive / Junior Manager Experience : 02 to 07 years in FML RA field Education: B Pharm \ MSc \ 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 revisions to submissions. Conduct meetings with cross-functional teams (CFT) to address deficiencies received from regulatory authorities and customers. Draft responses to regulatory deficiencies and review comments. Update the database as per requirements. Prepare the applicant and restricted parts for Abbreviated New Drug Applications (ANDAs). Compile dossiers in electronic Common Technical Document (eCTD) and Common Technical Document (CTD) formats for all relevant countries. Guide the CFT based on current requirements from regulatory authorities. Plan and allocate projects within the team. Assess proposed changes for approved products and finalize the submission category. Review and clear specifications, protocols, stability data, bio-waivers, etc. Key Performance Indicators: Demonstrate in-depth knowledge of regulatory guidelines and requirements for each market. Ensure all submissions are cleared within the stipulated timeline. Provide actionable items to address regulatory queries and dossiers. Required skills : Knowledge of RA Guidelines and Requirements Action Item for RA deficiency. Cross-Functional Team Work Represent regulatory affairs at cross functional meetings and coordinate with R&D, Production, Plant QA/QC and Marketing to efficiently and successfully complete regulatory activities Support plant teams in regulatory audits, liaison with domestic & export regulatory authority. Assess and approve change controls and update files accordingly Interview Date : 06-09-2025 Department : Regulatory Affairs - FML Dept. Experience : 02 to 07 Years Position: Executive / Senior Executive / Junior Manager Work Location : MSN R&D Center, Pashamylaram, Hyderabad Interview Venue: MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 06-09-2025.

Role & responsibilities To explore in-licensing partners for RoW markets (Asia , Middle East , Africa) Project Management for RoW markets New Product identification and Portfolio management. Good knowledge of Regulatory guidelines for above markets. Commercial evaluation of the business case to make it viable to execute new business/ existing business Manage timely delivery of projects by keeping track of all internal activities. Take responsibilities for business development activities in the designated markets. Launch executions, critical order management for designated business Manage customer relationship, retain and grow existing business Sound analytical & logical skill, ability to learn & develop skill Good communication & presentation skills• Preferred candidate profile Graduate in Science / Pharmacy / Engineering (related to Bio) and post-graduation in Science or Management or Pharmacy Experience: Minimum 3 4 Years of relevant experience Attributes: Ability to multitask, Capabilities in strategically & analytical thinking, operational planning, creative execution with excellent communication skills (written and oral) will be key requirements

Role & responsibilities Keep track of new inquiries from customers and add new customers for ROW, MENA, LATAM, ASEAN, EUROPE markets Generate new leads for customers from online platforms, website, exhibitions, etc Make promotional material, banners, stall design for exhibitions Attend exhibitions on behalf of the company Prepare and execute Annual promotional budget presentations for development of exports Preparing marketing literature, presentation, write ups for various products of the company as well as for the company Co-ordination with Artists for designing of various print promotional materials as well as online promotional material Promoting company as well as products on various online platforms and portals Keeping the company website up to date with latest updates in coordination with the agencies Propose new products for introduction in the market Preferred candidate profile B. Pharm with MBA or M. Pharm or Science background with MBA 5 to 7 years experience in business development of Pharma Exports Fluency in English (Read, Write, Speak) Fluency in Excel and PowerPoint Good communication skills