55 Product Registration Jobs

Develop&Execute creative international marketing& customer outreach strategies&Market research Identify, qualify&convert new international customers Build&manage strong customer relationship Provide regular sales performance updates to Sr. Management Required Candidate profile Strong understanding of intl. markets& business model Excellent communication, presentation& negotiation skills Experience in pharma exports/Life Sciences Excellent communication, presentation& skills Perks and benefits Salary Negotiable based on Experience& Skills

Key Responsibilities Prepare, review, and submit product registration and renewal dossiers (CTD/ACTD) for Europe and Southeast Asia markets Understand, interpret, and implement regulatory guidelines applicable to different European Union and Southeast Asia countries Prepare and renew registrations, manufacturing licenses, product approvals, WHO-GMP certificates, CPP/COPP, FSC, MSO registrations, and other regulatory documentation required by health authorities Lead the preparation, review, and submission of regulatory dossiers and documents to relevant authorities across Europe and Southeast Asia Respond to queries, variations, clarifications, and provide additional information to regulatory...

To look after the territorial sales set up in terms of all aspects including achieving sales targets & managing the territorial distribution network Responsible for establishing strong customer base for all the products in the assigned territory KRAs & Specific Roles: Customer management Develop strong Key Opinion Leader (KOL) base Quarterly update of database of customers Registering the products Understanding the market, the customer and the competition Conducting CME'S Target achievement Achieving sales as per targets in terms of value & units Achieving desired market shares in defined area Procuring & forwarding tenders immediately to the superior & HO Creation of new accounts Reports Da...

Role & responsibilities Prepare, review, and submit regulatory dossiers for product approvals, renewals, and variations in compliance with local and international regulations. Ensure all regulatory submissions are complete, accurate, and timely in alignment with organizational objectives. Maintain updated knowledge of regulatory requirements, guidelines, and changes across domestic and international markets. Coordinate with R&D, QA/QC, production, and marketing teams to gather technical data required for submissions. Manage regulatory databases, track approval timelines, and ensure documents are archived systematically. Respond to queries from regulatory authorities and provide clarification...

Role Description: The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...

The Territory Sales Manager will be responsible for managing and expanding the sales operations within the assigned territory. The role involves achieving sales targets, managing the territorial distribution network, and building a strong customer base for all products. Key Responsibilities: Sales Management: Achieve sales targets in terms of value and units while ensuring desired market share in the assigned territory. Customer Management: Establish and maintain a strong customer base, regularly updating the database of customers. Key Opinion Leader (KOL) Development: Develop and maintain relationships with KOLs to support product promotion and market presence. Market Analysis: Understand m...

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...

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 registration strategy fo...

Regulatory documentation, CTD/eCTD dossier preparation, product registration, license renewal, CDSCO guideline knowledge, and coordination with QA/QC/Production. Freshers welcome. Hybrid work mode.

Manage timely and professional delivery of regulatory activities for relevant products pro-actively to support the business goals including management of rationalization dossiers & related activities for Export products registration/renewal/variation for drug/ food/ other commodities items Represent organization while responding to regulatory agencies queries and other correspondence after engaging and interacting with regulatory bodies of various countries Preparing, submitting, reviewing regulatory file applications and supporting documentation with all registration related tasks post approval authorization, queries, post approval authorization-variations, renewals, fees (Pharmaceutical, N...

Title: Regulatory Officer We are seeking a detail-oriented Regulatory Officer with hands-on experience in handling export regulations for pharmaceutical products across African and Middle Eastern markets. The ideal candidate will have a science background and be well-versed in regional regulatory frameworks, dossier preparation, and registration processes. Key Responsibilities: Prepare, review, and submit registration dossiers as per country-specific guidelines. Ensure compliance with regulatory requirements for product exports to Africa and the Middle East. Liaise with local authorities, distributors, and regulatory consultants. Monitor changes in regulatory policies and update internal tea...

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...

Company Description Cipco Limited, established in 1989 and based in India, specializes in the manufacturing and export of high-quality generic and branded tablets and syrups. With a vision to provide affordable pharmaceutical products without compromising quality, the company is committed to building strong and lasting relationships with clients. Cipco Limited prioritizes addressing customer queries promptly and effectively. Role Description This is a full-time, on-site role for a Business Development Executive, located in Indore. The Business Development Executive will be responsible for identifying and generating new business opportunities, maintaining client relationships, and driving com...

MAIN PURPOSE OF ROLE Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function. First level manager of a work team that may comprise professionals, technical and/or administrative staff. Typically without budget or hire/fire authority. Focuses on mentoring, coaching, and coordination. Main Responsibilities As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout...

Prep. of CTD, ACTD dossiers, Tender Doc. Artwork & Sample checking Maintaining info in a variety of formats Writing comprehensible, user friendly, clear product info leaflets & labels Ensuring quality standard & submissions on time Prep. documents Required Candidate profile To ensure products comply with regulations of International Licensing Auth. To keep updated with international legislation, guidelines & practices of countries Good English Command, Word & Excel must.

Company Profile: At Sea6 Energy we envision a future where we can harness the potential of the oceans to provide sustainable solutions in energy, agriculture and food. To accomplish this, a multidisciplinary team with professionals from diverse fields of science including Industrial automation, Biotechnology, Agriculture, Ocean Engineering, Bioprocess Engineering, Marine biology and Aerospace Engineering all with the goal of building a whole new economy based on the oceans. Sea6 Energy is exploring new and innovative ideas and endeavours to generate technologies that add value to people's lives at every stage of its operations. Job overview: Sea6 Energy is looking for a candidate with abilit...

Roles and Responsibilities Taking care of Business development activity in the territory of LATAM Quoting in country tenders Customer service Coordinate with regulatory team and file dossiers in the respective territory. Maintain relation & coordination with agent and get the registration. relationship in Latem agents to develop the business. MS EXCEL, Power Point (Mandatory Requirement). Require to develop business in LATAM market Desired Candidate Profile Strong Communication Skills (Verbal & Written). Must possess excellent organizational, administrative, management and decision making skills. MS-Office Skills Self motivated, Team Management Experience Perks and Benefits Best in the Indus...

Responsibilities. Global Product Registration & Dossier Management Lead the full registration lifecycle (pre-market research, submission, renewal) for all target export countries. Compile regulatory dossiers, including 5-batch analysis and efficacy data, ensuring strict adherence to national formats. Serve as the primary Point of Contact (POC) to coordinate data between R&D, factory, customers, and regulatory authorities for seamless submissions. Compliance and Policy Monitoring Monitor global regulations (e.g., MRLs, restrictions) and communicate changes to ensure continuous company compliance. Verify GLP/quality compliance of all required efficacy, toxicity, and environmental studies prior...

SR. Executive/Assistant Manager/Manager - Regulatory Affairs Roles and Responsibilities - To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. - To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSC- Procuring and legalization). - To check & approve the artworks for regulated / semi regulated countries. - To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. -Handling queries pertaining to regulatory submissions from various regulatory authorities. - Maintain re...

Documentation & SOP Management Prepare and implement standard operating procedures, batch manufacturing records, protocols, cleaning procedures, and log sheets. Maintain all documentation in compliance with cGMP and regulatory requirements. Ensure timely review and revision of SOPs related to FP departments. Quality & Compliance Activities Handle QMS activities including change controls, deviations, incidents, and risk assessments. Perform DQ, IQ, OQ, and PQ qualifications for equipment. Support in audit preparedness and ensure all documentation is audit-ready. Training & Team Management Ensure departmental employees are trained as per the TRIMS training schedule. Attend and ensure participa...

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulat...

preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission Preparation of respective CTD sections and submission of final query response to agency Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval To upload documents in national portal for respective European regulatory agency Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation Review of the mockups for all regulatory submissions and commercial supplies Maintenance of internal database Co-ordination with consulta...

Croda is a FTSE100 organisation focused on our purpose of Smart Science to Improve Lives. With a market capitalisation of 6 billion and nearly 6,000 employees globally, we are innovating new and novel ingredients for the Life Sciences industry through our commitment to sustainability and customer centricity. As our Seed business looks to deliver its ambitious strategy of growth, we are looking for a Seed Technology R&D Leader to join our organisation to Lead the Seed Technology Research & Development function across India, focusing on innovation, product development, and technical support for seed enhancement technologies. Drive strategic research initiatives aligned with global and regional...

Job Title: R&D Manager Department: Research & Development, Quality Control Location: Dhamdod Factory Reporting To: Director, Research & Development Employment Type: Full-Time Job Summary: The R&D Manager will oversee research and development activities to innovate and improve fertilizer formulations and production processes. The role also includes managing the quality control function to ensure all products meet regulatory standards and customer specifications. The candidate should possess strong scientific knowledge, regulatory awareness, and leadership skills to drive technical excellence. Key Responsibilities: Develop new formulations for fertilizers, biofertilizers, and micronutrient ble...

We are seeking an experienced and detail-oriented Executive Regulatory Affairs (ROW) to join our Regulatory team. The ideal candidate will be responsible for preparing, reviewing, and submitting dossiers for semi-regulated and non-regulated markets, ensuring compliance with global regulatory requirements, and coordinating with internal departments and external stakeholders for product registration and documentation. Key Responsibilities: Prepare and compile regulatory dossiers for semi-regulated and non-regulated markets (ROW). Respond to queries and deficiencies raised by the Ministry of Health (MOH) or buyers related to dossiers and submissions. Coordinate the arrangement and dispatch of p...