51 Product Registration Jobs - Page 2

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 ...

This vacancy has expired This doesn't mean the journey ends here. Click below to continue your new career path. 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 Regulatory Product Chemistry documentation, facilitating the acquisition and maintenance of registrations in AMEA in alignment with business objectives. Contribute to the continuous improvement and operational excellence of the CP Product Chemistry Team. Accountabilities Manage the technical aspect (regulatory chemistry) of a portfolio of active ingredients and their corresponding mar...

Manage all the business discussion and relationship with existing customers Conduct internal and external analysis on customer’s business Communicate effectively with the client and respond to complex queries with regards to contract obligation Required Candidate profile • Ability to effectively participate in cross functional commercial teams and present results/recommendations to stakeholders and management at plant sites and headquarters when necessary

We are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines, and handling ROW, LATAM, SEA, Africa, Pacific market approvals. The candidate will also coordinate BE studies, manage lifecycle activities, review technical files, liaise with authorities, maintain regulatory records, and mentor junior team members.

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 &...

Objectives Of The Position Responsible for Regulatory strategy of South Asia, ASEAN, ANZ (close collaboration with strategic Regulatory management team) Responsible for all compliance activities in South Asia, ASEAN, ANZ Responsible for all registration activities in South Asia, ASEAN, ANZ Consolidate and communicate prioritization of product registrations and regulatory submissions Provide customer support beyond BASF for end users, supporting customers in preparation of drug product submissions and responses to deficiency questions from Health authorities Consolidate and communicate development in the South Asia, ASEAN, ANZ regulatory environment Regulatory representative for BASF Pharma i...

About Zydus Wellness Zydus Wellness, an FMCG leader, develops, manufactures, and markets health and wellness products, integrating healthcare, skincare, and nutrition. Founded in 1988 with Sugar Free, India’s first zero-calorie sugar replacement, it now manages seven global brands, including Complan, Glucon-D, Everyuth, and Nutralite. The company serves over 50 million families and supports more than 90,000 dairy farmers and 2,000 MSMEs. With a focus on research, quality, and innovation, Zydus Wellness operates on core pillars of manufacturing integrity and supply chain efficiency. Headquartered in Ahmedabad and Mumbai, it runs four manufacturing facilities across India and eight co-packing ...

Role & responsibilities 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 timel...

Do you want to contribute to the future of healthcareAs Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer. We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting Then come in and join India team as Regulatory Affairs Specialist. Your tasks and responsibilities: Planning and preparing product related medical device submissions for the products manuf...

Manage all the business discussion and relationship with existing customers Conduct internal and external analysis on customer’s business Communicate effectively with the client and respond to complex queries with regards to contract obligation Required Candidate profile • Ability to effectively participate in cross functional commercial teams and present results/recommendations to stakeholders and management at plant sites and headquarters when necessary

1. Regulatory Submissions: Preparation and compilation of dossiers in CTD/eCTD formats for domestic and international markets (ROW countries). Submission of registration applications for new products and variations (post-approval changes). 2. Documentation: Review and verification of technical documents such as Product Information Leaflets, Labels, SPC, COAs, Stability Data, Product Development Reports, etc. Coordination with R&D, QA, QC, and production teams for required documents and data. 3. Regulatory Compliance: Ensure products and documentation comply with applicable regulations and guidelines (ICH, WHO, FDA, EMA, CDSCO, etc.). Monitor regulatory changes and ensure timely updates to in...

Roles & Responsibilities: 1. Product Registration: Handle the registration of products under FDCA (Food and Drugs Control Administration) for necessary approvals. 2. Label Claim Verification: Coordinate with the Formulation & Development team to confirm and validate claims mentioned on product labels and the regulatory classification of each product. 3. Artwork Coordination: Work closely with the sales team to ensure that product artworks (for existing and new products) meet all relevant regulatory requirements. 4. Renewals & Compliance: Manage the timely renewal of product approvals under applicable regulatory bodies, maintaining full compliance throughout the product lifecycle. Qualificati...

We are seeking a highly skilled and driven International Business Development Manager to lead our pharmaceutical business expansion across Latin American (LATAM) markets. The candidate must possess a solid understanding of regulatory affairs, export documentation, and client account management within the pharmaceutical domain. Key Responsibilities: Drive business development in new territories across Latin America by identifying potential clients, partners, and distributors. Initiate and coordinate new product development based on client-specific and regional requirements. Manage and nurture long-term relationships with existing international clients and consistently seek opportunities to gr...

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 ...