43 Product Registration Jobs

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...

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining impossible. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Service Manager - RAD YOUR TASKS AND RESPONSIBILTIES: To be responsible for the Bayer Radiology (devices) and Service initia...

Position: Senior Regulatory Affairs Manager Global Cosmetics Compliance Department: Regulatory Affairs / Operations Reports to: COO (Integrator) & CEO Location: India, Noida- Sec- 63 Employment Type: Full-time Shift Time- 12 PM IST- 9 PM IST About CBAYEXPRESS / Herbishh: CBAYEXPRESS CORPORATION is a Canadian-based e-commerce company selling across Amazon (US, CA, MX, UK, EU, AU, SG, IN, UAE), Walmart, Shopify (Herbishh.com, BisonBody.com), eBay, and other marketplaces. Our flagship brand Herbishh is a leader in haircare and beauty, with rapid global expansion. With $15M+ annual revenue, we are scaling towards $30M+ globally, and compliance is a key pillar of our success. Role Overview: We ar...

Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations. Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements. Regulatory Compliance & Communication Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines. Review and submit annual reports, amendments, variations, and renewals as required. Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner. Documentation & Data Collec...

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...

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...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise 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 -Advises Global teams on regulatory impl...

Company Description We are a leading, science-based agriculture company, empowering farmers to meet the demands of modern agriculture. Using cutting-edge innovation, we help farmers to grow resilient, healthy crops that can feed a growing global population, while promoting sustainable farming practices that protect and enhance our planet. Headquartered in Switzerland, we are a global agritech leader with more than 30,000 employees across over 90 countries. https://www.syngenta.com/company Job Description Purpose To establish and sustain a leading position in Product Chemistry within the AMEA region. Empower the global CP regulatory organization by providing comprehensive and up-to-date Regul...

Job Position: Cosmetics Regulatory Affairs Specialist Working Days: Monday to Friday Shift Time- 12 PM IST- 9 PM IST On-Site Role We are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory policies, documentation, and compliance requirements related to cosmetics. This role will be responsible for ensuring that all products meet local and international regulatory standards. Key Responsibilities: • Prepare and submit regulatory documentation for cosmetic product approvals and registrations. • Ensure compliance with all relevant regulations, guidelines, and standards related ...

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward we explore, learn and look for new ways of doing things. The Role Develop, execute, and communicate the marketing plan for the Wound & Skin Care product range in India, consistent with global strategy. Lead the marketing efforts including pricing, market analysis, product improvements, and promotional strategies...

The role involves preparing and reviewing regulatory documents, ensuring compliance with national and international guidelines, and supporting product registration processes. Required Candidate profile Looking for a Regulatory Affairs Officer with 2-3 years of experience in the Pharma/API sector. Candidates should have strong MS Office skills and good communication abilities.

Dossier Preparation & Compilation: Lead the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring adherence to country-specific regulations. Regulatory Strategy & Market Compliance: Develop and implement regulatory strategies for product approvals across ROW, LATAM, SEA, Africa, and Pacific regions. Bioequivalence Studies & Compliance: Coordinate with CROs to ensure compliance and timely approval of bioequivalence studies for international submissions. Product Lifecycle Management: Oversee regulatory activities throughout the product lifecycle including renewals, variations, and post-marketing compliance. Product Registration &...

JOB DESCRIPTION: MAIN PURPOSE OF ROLE Summarize the main purpose of the role. Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. MAIN RESPONSIBILITIES . As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. . Interacts with regulatory agency to expedite ...