71 Regulatory Documentation Jobs - Page 3

Key Responsibilities: Develop and validate analytical methods using HPLC, UV, IR, and GC. Prepare protocols and reports for method development and validation. Perform stability studies and sample analysis for new products. Maintain instruments and lab notebooks as per SOPs and GMP guidelines. Coordinate with formulation development and QA teams. Requirements: M.Sc. / B.Pharm / M.Pharm in Chemistry/Pharmaceutical Sciences. Knowledge of ICH guidelines and regulatory documentation. Hands-on experience with chromatographic techniques and software. Analytical Method Development of Assay, Related Substances, Residual Solvents & Dissolution Test Methods with Literature Search & Report.

R&D Executive (Food Technologist) with 3+ yrs experience in NPD, formulation, and tech transfer for nutraceuticals. Expertise in FSSAI compliance, ingredient selection, and product development. Location: Mohali. B. Tech in Food Tech required.

Serve as the Subject Matter Expert (SME) for counterparty onboarding, refresh processes across various markets and asset classes. Collaborate with broker-dealer counterparties Liaise with internal stakeholders Required Candidate profile Track onboarding milestones to ensure timely submission execution of onboarding steps. Maintain relationships with both external brokers internal business units. Leverage an in-depth understanding Perks and benefits Perks and Benefits

Title We are currently seeking an full time office based Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India Mumbai. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least 4 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Role & responsibilities Position: Regulatory Associate CMC Location: Remote (India) Were looking for passionate professionals ready to grow their careers in a dynamic, global organization. Role Requirements: Masters degree in Pharmaceutical Sciences Minimum 2 years of experience in regulatory, quality, or document management support Hands-on experience with CMC (pre- and post-approval) Familiarity with Module 1 document preparation and country-specific administrative forms Skilled in maintaining regulatory trackers, submission timelines, and status reports Strong interpersonal and communication abilities Proficient in Microsoft Office (Word, Excel, PowerPoint) Be a part of meaningful work that impacts patients' lives around the world. QUALIFICATION REQUIREMENTS Masters in pharmaceutical sciences. Minimum around 2 years of experience in a regulatory, quality, or document management support role. Excellent interpersonal / communication skills. Advanced skills in Microsoft Office Applications. Good time and project management skills, preferred. Strong analytical skills and attention to detail. Ability to work both as a team member and independently and to understand and carry out detailed instructions. Ability to interact with staff from multiple departments. Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred.

Role & responsibilities Media section prepares small and bulk volume of media to produce FMD/HS antigens and related to cell and virus/ Bacterial culture sections To update the regulatory documents online Involved in microbial upstream and primary downstream processes Coordinating with internal and external departments like QC, QA, and engineering. Coordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machines Preferred candidate profile Should have experience in handling various bioreactors adherent and suspension cell cultures, cell passaging. Exposure to regulatory audits.

Prepare, submit regulatory dossiers for new product registrations Coordinate and manage the submission of regulatory documents Facilitate communication with health authorities, responding to queries Required Candidate profile M. Pharm (Female Candidate Preferred) 1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired. Excellent communication skills.

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: USA based Pharma Company Position: Executive - Regulatory Affairs (Formulations for USA market) Department: Regulatory Affairs Location: Ahmedabad Job Profile: Responsible for supporting the Regulatory Affairs department in its efforts to remain in compliance with the regulations of all intended market territories (USA Market). Regulatory support for assigned projects through product development and lifecycle management of products for US market. Review and approve labels in line with US regulatory requirements for assigned products. Prepare, develop, and maintain internal Regulatory informational trackers. Prepare technical documents required for submission of dossier as per country specific requirements. Respond to consumer inquiries based on approved labels and product information. Coordinate the receipt of raw material regulatory documents from vendors. Preparation of module 1 sections including labelling sections. Perform drug listing of assigned products for US market. Support publishing of ANDA submissions Support manufacturing site for commercialization and life cycle management of the approved products. Other projects and duties as assigned by Senior Management. Desired Profile: B.Sc / B.Pharm / M.Sc / M.Pharm with 2 to 5 years experience in US regulatory affairs Labelling department with growing & well established pharmaceuticals. OTC products Experience is a Plus. Must have good exposure in supporting role of ANDA filling for USA market. Exposure in Solid Oral (Tablets & Capsules) for regulated markets (USA) would be preferred. Exposure to working in US Markets is Mandatory. Ability to compile, manage and interpret data. Ability to work both independently and within a team environment. Ability to manage several tasks simultaneously. Ability to co-ordinate & manage the project with external stake holder. Effective communicator with excellent relationship building & interpersonal skills. Proficiency in Microsoft Office and Adobe Acrobat. Strong communication skills, both verbal and written. Strong organizational skills. Recruiter's Contact Details: BEST-FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722042906, 09722052906 E-Mail: post@bfrr.in Website: www.bestfitrecruitment.co.in

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 Generation Team, Global Safety Team, Label Working Group) Provide functional area input for Global Regulatory Plan and team goals Collaborate with contract and freelance writers as needed Participate in training and mentoring junior medical writers Engage in departmental and cross-departmental initiatives Generate document timelines with team input Stay updated on relevant professional information and technology Basic Qualifications Doctorate degree OR Master's degree with 46 years of directly related experience OR Bachelor's degree with 68 years of directly related experience OR Diploma with 1012 years of directly related experience Preferred Functional Skills Proficient with Microsoft Word and Office programs Strong knowledge of scientific/technical writing and editing Thorough understanding of clinical development processes for new compounds Ability to understand and follow complex SOPs, guidance documents, and work instructions Substantial knowledge of ICH and Good Clinical Practice (GCP) guidelines and requirements Soft Skills Excellent written and oral communication skills with strong attention to detail Demonstrated leadership abilities within a team environment involving negotiation, collaboration, and analytical judgment Effective time and project management skills Self-motivated with drive and perseverance to achieve results

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/ regulatory compliance efforts with contract manufacturers, for a new pharmaco is preferred. Role & Responsibilities Inspection & Audit of contract manufacturers : Quality Oversight Ensure that select CDMOs comply with GMP, ISO standards, and other regulatory guidelines applicable to the pharmaceutical industry Conduct regular audits Ensure batch reviews & quality controls throughout the production process Product Quality Assurance: On site Conduct extensive QC and batch reviews for product on the CDMO manufacturing site Off site Conduct product reviews after receipt at warehouse Regulatory Compliance & Documentation : Drive regulatory compliances in terms of product & process quality; liaison with respective regulatory bodies Documentation - Proper documentation and compliance with product quality requirements for regulatory submissions and inspections Additional Information Ensure product quality and regulatory compliance for a new Trade Generics business. Collaborate on QA/QC of CDMOs and final products. Conduct audits, inspections, and product reviews. Ensure regulatory compliance and documentation. 5+ years of pharmaceutical QA/QC experience with regulatory expertise.

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 manufacturing processes, and familiarity with pharmaceutical industry regulations. You will also contribute to technology transfer activities, troubleshoot synthetic issues, and ensure compliance with safety protocols. This role demands a proactive approach to staying updated on recent literature, participating in team discussions, and supporting the preparation of technical reports and regulatory documentation. Your expertise will directly influence the efficiency and quality of our API development pipeline, ensuring Glochem Industries maintains its position as a leader in the pharmaceutical industry. Job Details: Industry: Pharmaceuticals Department: Research & Development Role: Assistant Manager R&D Location: Hyderabad Compensation: 6-10 LPA Experience: 5-10 years Employment Type: Full-time Qualification: Master’s or PhD in Organic Chemistry or related field Responsibilities: Organic Synthesis and API Development Execute multi-step organic syntheses for API development, adhering to established protocols and under the guidance of senior scientists. Optimize reaction conditions to enhance yield, purity, and cost-effectiveness of API synthesis. Develop scalable and environmentally friendly synthetic routes for API manufacturing, considering green chemistry principles and Glochem Industries' sustainability goals. Troubleshoot synthetic issues during development, employing analytical techniques and literature review to identify and resolve problems. Ensure compliance with chemical safety procedures and handle hazardous chemicals responsibly, following GLP guidelines. Assist in the preparation of development summaries and technical reports, documenting key findings and experimental data for API projects. Research and Development Conduct literature searches and stay abreast of the latest advancements in organic chemistry and API development to identify innovative solutions. Design and execute experiments to investigate new synthetic methodologies and optimize existing processes for API production. Collaborate with cross-functional teams to identify and evaluate potential new API candidates for development. Contribute to the development of intellectual property, including patent applications, related to novel synthetic routes and API formulations. Analyze and interpret experimental data to draw conclusions and make recommendations for future research directions. Present research findings at internal meetings and contribute to the preparation of scientific publications and presentations. Project Management Assist in the planning and execution of API development projects, ensuring adherence to timelines and budgets. Track project progress and identify potential roadblocks, proactively proposing solutions to mitigate risks. Coordinate with internal and external stakeholders to ensure effective communication and collaboration throughout the project lifecycle. Contribute to the preparation of project reports and presentations, summarizing key findings and progress updates for management review. Participate in project team meetings and contribute to the development of project strategies and objectives. Manage laboratory resources and equipment to ensure efficient operation and support project activities. Compliance & Safety Ensure strict adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) guidelines in all aspects of API development. Maintain accurate and complete documentation of all experimental procedures, data, and results in accordance with regulatory requirements. Participate in internal audits and inspections to ensure compliance with company policies and regulatory standards. Implement and maintain a strong safety culture within the laboratory, promoting safe work practices and adherence to safety protocols. Conduct risk assessments for all experimental procedures and implement appropriate control measures to minimize hazards. Ensure proper handling, storage, and disposal of hazardous chemicals and waste materials in accordance with environmental regulations. General Expectations and Past Experiences: Master’s or PhD in Organic Chemistry with 5-10 years' API development experience in the pharmaceutical industry, focusing on organic synthesis and process chemistry. Independently execute and troubleshoot multi-step organic syntheses, optimizing reaction conditions for yield, purity, and scalability. Utilize NMR, HPLC, GC-MS, and LC-MS for sample analysis, characterization, and impurity profiling to support API development and process optimization. Maintain a strong understanding of FDA, ICH, and GMP guidelines to ensure regulatory compliance in R&D activities. Contribute to DMF submissions and other regulatory documents, ensuring accuracy and completeness. Participate in experiment design and execution for process development, optimization, and validation of APIs. Contribute to identifying and evaluating new technologies and synthetic methodologies to enhance API development capabilities.

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 parenteral drug delivery innovations. 5. Regulatory Documentation: Prepare and review CMC documentation for regulatory submissions, ensuring alignment with global health authority requirements (FDA, EMA, etc.). 6. Process Development & Optimization: Implement Quality by Design (QbD) and Design of Experiments (DoE) principles to refine injectable formulation strategies. 7. Cross-Functional Collaboration: Work closely with analytical, manufacturing, and regulatory teams to ensure seamless product development. 8. Troubleshooting & Problem-Solving: Address formulation challenges related to stability, compatibility, and manufacturing scale-up. 9. Innovation in Drug Delivery: Explore novel injectable delivery mechanisms, including depot injections, nanoparticle-based formulations, and biopharmaceuticals. 10. Leadership & Mentorship: Guide junior scientists, fostering innovation and technical excellence in formulation research. Qualifications: PhD/Masters in Pharmaceutical Sciences Extensive experience in sterile injectable formulation development with a strong track record of successful product launches. Expertise in aseptic processing, lyophilization, and excipient compatibility for injectables. Strong knowledge of scale-up processes, technology transfer, and industrial manufacturing practices. Proven ability to develop and optimize parenteral drug formulations, ensuring quality and regulatory compliance. Experience with regulatory pathways, and ANDA submissions. Understanding of bio pharmaceutical characterization for injectable products. Preferred candidate profile Candidate with exp of Pre-Formulation Studies and research Candidate with experience of successful scale-up from lab-scale development to pilot and commercial manufacturing, ensuring reproducibility candidate with Sterile Manufacturing Expertise. candidate with experience in Innovation in Drug Delivery: novel injectable delivery mechanisms, including depot injections, nanoparticle-based formulations, and biopharmaceuticals.

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 submission. Qualifications: PhD/Masters in Pharmaceutical Sciences. Significant experience formulation development and OSD technologies. Strong understanding of regulatory requirements for OSD products. Proficiency in QbD , DoE , and process optimization. Preferred candidate profile 1. Experience of compliance with regulatory guidelines and GMP standard 2. Hands on experience of Pre -formulation studies , compatibility Assessment , stability Testing

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, ensuring successful transition from laboratory to pilot and commercial-scale production. 7. Manage technology transfer processes across manufacturing sites to ensure formulation integrity and reproducibility. 8. Prepare and review regulatory documentation, including CMC sections for global submissions. 9. Ensure compliance with GMP standards and regulatory guidelines for peptide drug formulation. 10. Utilize QbD and DoE principles for formulation optimization and process development. 11. Provide scientific leadership and mentorship to junior scientists within the formulation team. Qualifications: PhD/Masters in Pharmaceutical Sciences, or industrial Pharmacy Extensive experience in peptide formulation and oral solid dosage technologies. Strong expertise in excipient selection, stability enhancement, and formulation optimization. Understanding of global regulatory requirements, including expertise in preparing regulatory submissions and ensuring compliance with CMC guidelines. Ability to drive innovation in peptide formulation strategies and drug delivery systems. Preferred candidate profile OSD Experience at least 4 years of experience in peptides Experience of peptide formulation research, including biopharmaceutical characterization and analytical methodologies. l Hands-on experience in scale-up processes and successful technology transfer for peptide-based OSD formulations. l Knowledge of sterile manufacturing principles, which can be beneficial for peptide drugs requiring specialized handling.

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 Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.

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 general supervision, collects manual and electronic signatures in compliance with GCP. Tracks and updates time-sensitive documentation for active Readers/Consultants. Consistently follows mandatory naming conventions and file structure requirements. Manages database and department file store to ensure audit readiness. Maintains confidentiality of project, budget, and protected health information (PHI) in strict compliance with company procedures and policies and regulatory requirements. Participates in building Reader relationships through responsive interaction with institutions, Reader vendors, and individual physicians. Contributes to process improvement initiatives. Exhibits a team approach with a positive, flexible attitude toward work assignments and learning. Preferred candidate profile Degree or equivalent work experience is required. Experience in clinical research or imaging related field preferred. Excellent verbal and written communication skills in the English language. Proficiency with using MS Office software. Strong customer orientation. Ability to work independently, effectively organize and prioritize tasks, and meet deadlines in a dynamic environment. Good problem-solving skills. Accurate and detail-oriented.

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. Regulatory Compliance : Support health authority query responses, internal audits, and inspections, ensuring adherence to SOPs and APAC regulations. Collaboration & Training : Act as the regulatory lead for biosimilar projects, train teams on APAC eCTD requirements, and align with CMC, Clinical, and Quality teams for data integrity. Required Qualifications 4-14 years in regulatory affairs (pharma/life sciences). Experience in reviewing documentation related to biosimilars submissions across Asia markets Expertise in CMC Module 3 , eCTD compilation , and APAC regulations (PMDA, NMPA, DCGI). Bachelors/Masters in Pharmacy or Life Sciences. Strong attention to detail and ability to meet deadlines.