145 Row Market Jobs - Page 4

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 ne...

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 produc...

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 submis...

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 s...

"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, LAT...

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 oth...

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...

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...

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 wel...

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....

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 Pr...

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, ...

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 lea...

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 on...

Role & responsibilities Candidates having experience working for Russia, CIS, APAC, SSA (Sun Saharan African) and Brazil /LATAM market

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format. Ensure compliance with USFDA regulations through dossier compilation and submission. Manage RA activities from pre-clinical to post-marketing stages, covering both domestic and international markets. Develop expertise in drug regulatory affairs, focusing on row market requirements. Collaborate with cross-functional teams to ensure timely completion of projects.

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 EU, ROW Markets. Various Countries Location-Pune Corporate Office (S. B. ROAD - SHIVAJI NAGAR, PUNE ). This is a Office Based Job (Pune), Profile : Handle Current Export Business Clients smoothly Co-ordination with client and factory for timely delivery of goods.Coordinate with Regulatory Department to ensure proper dossier submission and getting MA. Required Candidate profile Good Communications Skills Honest, Hard Working Growth Mindset (Important) Ambitious & Positive Thinker 5-12...

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.