170 Regulatory Documentation Jobs - Page 7

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Roles & Responsibilities Author regulatory submission documents such as: Clinical Study Reports Investigator Brochures Responses to Questions Protocols and Protocol Amendments Informed Consent Forms Table of All Studies Clinical Overview Addenda eCTD Module 2 Clinical Summary Documents Briefing Documents Pediatric Investigation Plans Other regulatory documents as assigned Conduct formal review and approval of authored documents, adhering to SOPs Manage regulatory writing activities for product submissions under supervision, including new and supplemental drug applications/biologics license applications Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Gen...

Key Responsibilities: Manage the overall Quality assurance and Quality Check of products Responsible to ensure that that all products meet the highest standards of quality, safety, and regulatory compliance for a new Trade Generics business Work closely with the senior advisor & procurement manager for QA/QC of contract manufacturers & final products Initially report to promoter and later to Ops & Supply Chain Head Experience 5+ years of experience as a quality manager/ executive in the pharmaceutical industry, with strong knowledge of regulatory standards is must. Relevant roles: Quality Manage/ Quality executive of a pharmaceutical company Experience with leading the audit/ inspection/ reg...

Manage EMA registrations, liaise with authorities (EMA, BfArM, PEI), handle PI submissions, packaging, approvals. Review SmPC, PILs, labels, texts. Support RA team and associates, assist with data entry, invoicing, presales, and ensure EU compliance.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

We are looking for a meticulous Assistant Manager R&D to spearhead API development initiatives at Glochem Industries. As Assistant Manager, you will play a crucial role in executing complex organic syntheses, optimizing reaction conditions, and assisting in the development of scalable and environmentally friendly synthetic routes for API manufacturing. Your responsibilities will span from meticulous documentation of experimental procedures and results to collaborating with cross-functional teams, including analytical, kilo lab, and pilot plant teams, for sample analysis and process scale-up. The ideal candidate will have a strong foundation in organic chemistry, a deep understanding of API m...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products

Role & responsibilities Experience: 9-14 years Specialization: Injectable Drug Formulation & Development Key Responsibilities: 1. Formulation Development: Lead the design and optimization of injectable drug formulations, ensuring stability, efficacy, and manufacturability. 2. Pre-Formulation Studies: Conduct compatibility assessments, stability testing, and excipient selection to enhance product quality. 3. Scale-Up & Technology Transfer: Oversee successful scale-up from lab-scale development to pilot and commercial manufacturing, ensuring reproducibility. 4. Sterile Manufacturing Expertise: Manage aspects of sterile formulation processes, including aseptic techniques, lyophilization, and pa...

Role & responsibilities Experience: 9-14 years Specialization: Oral Solid Dosage Key Responsibilities: 1. Develop and optimize formulations for OSD drug products. 2. Conduct pre-formulation studies, compatibility assessments, and stability testing. 3. Lead formulation development for OSD products, including tablets, capsules, and granules. 4. Design and optimize OSD formulations, ensuring stability and efficacy. 5. Work closely with manufacturing teams for scale-up and technology transfer of OSD formulations. 6. Ensure compliance with regulatory guidelines and GMP standards. 7. Innovate in OSD drug delivery systems and formulation strategies. 8. Develop regulatory-compliant documentation for...

Role & responsibilities Experience: 9-14 years Specialization: Oral Solid Dosage with at least 4 years of experience in Peptides Key Responsibilities: 1. Lead formulation development for OSD products, including tablets, capsules, and granules. 2. Develop and optimize stable peptide formulations for OSD applications. 3. Conduct pre-formulation studies, compatibility assessments, and stability testing for peptide-based formulations. 4. Innovate in drug delivery strategies, ensuring enhanced bioavailability and release kinetics for peptide-based OSD formulations. 5. Work closely with analytical teams to characterize formulations using advanced techniques. 6. Oversee scale-up activities, ensurin...

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmac...

Role & responsibilities Capable of implementing applicable procedures and associated documents. Supports team members with the fulfillment of requests from Quality Assurance. Assists team with responding to and tracking the fulfillment of general requests to Read Services. Follows general Decision Tree guidelines when liaising externally. Under general supervision, uses software tools to facilitate document collaboration. Produces clean, final legal & regulatory documents from templates and enters data accurately into designated tracking systems while maintaining data type and formatting requirements. Assists with contract preparation, onboarding, and vetting of Readers/Consultants. Under ge...

Title: Regulatory Affairs-CMC (Junior-Senior level) Location: 100% REMOTE Experience: 4-14 Years Industry: Pharmaceuticals / Life Sciences Job Overview Join our team as a Regulatory Affairs Specialist with 4-14 years of experience in pharmaceuticals or life sciences. We seek a detail-oriented professional skilled in CMC Module 3 preparation and eCTD dossier compilation to ensure compliance with global and Asia market regulatory standards. Key Responsibilities eCTD Dossier Compilation : Draft, Review and compile CTD/eCTD modules, ensuring accuracy, consistency, and alignment of Modules 2.5, 2.7, 3 and 5 with biosimilar justifications. Conduct gap analyses and coordinate corrections. Regulator...

Job Title: Senior Regulatory Executive RoW Market ( LATAM Specially) Location: Ahmedabad Experience: 5–7 years in Regulatory Affairs (RoW markets) Qualification: B.Pharm / M.Pharm / Life Sciences Key Responsibilities: Prepare & review CTD/eCTD/non-CTD dossiers for new registrations, renewals, and variations. Coordinate with agents/distributors for submissions and query responses. Track timelines and ensure compliance with regulatory guidelines (LATAM, Africa, CIS, Asia). Manage product lifecycle: variations, renewals, packaging/labelling updates. Maintain regulatory databases and trackers. Key Skills: Strong knowledge of RoW regulatory requirements & dossier formats. Experience with LATAM co...

Job Purpose: To lead and support regulatory operations for agrochemical products across the Asia Pacific region, ensuring compliance with local regulations, facilitating product registrations, and enabling market access. This role is critical in aligning regional regulatory strategies with global business objectives. Regulatory Compliance & Strategy Monitor and interpret regulatory requirements for agrochemicals (e.g., pesticides, herbicides, fertilizers) across APAC countries. Develop and implement regulatory strategies to support product launches and lifecycle management. Liaise with regulatory authorities and industry bodies to stay ahead of regulatory changes and advocate for science-bas...

Job Summary: The Regulatory Affairs Executive will be responsible for ensuring that the company's precision optical products comply with all relevant regulatory standards and requirements in domestic and international markets. This role involves preparing and submitting regulatory documentation, maintaining compliance with industry standards (e.g., ISO, FDA, CE), and supporting product development teams with regulatory guidance throughout the product lifecycle. Key Responsibilities: Prepare, review, and submit regulatory documentation (e.g., technical files,declarations of conformity, 510(k), CE marking dossiers). Ensure ongoing compliance with applicable international regulations (FDA, EUMD...

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 ...

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client c...

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client c...

Key Responsibilities: BEE Documentation & Filing: Independently handle documentation required for BEE certification processes, including application preparation, data collation, and submission. Client Coordination: Act as a point of contact for clients seeking BEE compliance; guide them through process stages and requirements. Compliance Support: Ensure adherence to BEE norms and timelines; track client status and report non-compliance or delays to seniors. Internal Coordination: Collaborate with technical, testing, and documentation teams to gather required inputs and resolve client queries. Energy Data Analysis: Assist in basic verification and organization of energy-related product data t...