225 Regulatory Documentation Jobs - Page 8

Qualification: MSc in Analytical / Organic Chemistry Pharmacy Life Science Role Summary: Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance. Key Responsibilities: Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities. Ensure timely updates, maintenance, and life cycle management of submissions. Monitor global regulatory changes and communicate to internal teams. Handle customer queries, letters of access, and technical...

Primary Skills SAP PLM Recipe Development & Management Extensive experience in configuring and managing end-to-end recipe development processes within SAP PLM. Proficient in creating and optimizing formulas, defining ingredient compositions, and ensuring compliance with industry-specific regulations. Strong understanding of managing recipe versions, tracking modifications, and maintaining historical records for transparency and traceability. Specification and Compliance Management In-depth knowledge of handling raw material, intermediate, and finished product specifications. Ability to set up structured specification templates, define critical parameters, and ensure adherence to global regul...

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, an...

Candidate Profile: Minimum qualification should be Graduate in Chemistry (Hons) 2-5 years experience in a chemical laboratory doing analysis or R&D work or having experience in any kind of chemical regulatory work Have good hold on English language Dynamic and disciplined Have ability to do lot of data search on the internet and refer books & journals Have the interest to study and read documents thoroughly to analyse and understand Open to travel both within India and outside related to office work Have the ability to work in team and believes in teamwork Innovative and takes initiative

. Role & responsibilities Knowledge on Medical device regulations Good Communication skills Ability to read through the Medical Device Documents Ability to work on Microsoft tools (Excel, Word and PowerPoint) Experience on Medical Device UDI Data management will be an additional preference Preferred candidate profile Work location: Madurai Education: B.E Mechanical/Bio-Medical Experience: 6 months to 3 yrs Immediate joiners are only preferred. Interested candidates can share your resume to keeshouley.m@hcltech.com. Interview Mode - Scheduled Walkin (Need to report to Madurai premises for Face to Face Interview). Regards, Keeshouley M

Preparation, review and compilation of assigned ANDA/NDA [505 b (2)]/projects for filing and knowledge of eCTD, Module 2 and 3. Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms. Preparation, review and compilation of Supplements and Amendments. Review of Pharmaceutical Development Reports Review of manufacturing documents like batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, hold time study reports, master formula cards, master packaging cards etc. Review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer...

Associate - Clinical Quality Assurance (CQA) Department: QA - MakroCare and DDi Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct interna...

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 seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines. Key Responsibilities: Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control. Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution. Review and approve Master Production Records, Batch Production R...

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 Deliverables: Prepare regulatory documents ensuring anonymization and redaction compliance Develop and maintain written redaction strategies for studies/products Coordinate with cross-functional teams for review and timely submission Support trend analysis and clinical disclosure process improvement Role Responsibilities: Interpret and apply clinical data within regulatory frameworks Follow SOPs and controlled processes for document preparation Manage timelines and priorities to meet disclosure deadlines Communicate and escalate document or strategy issues as needed

The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the bank's clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating Procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help exe...

The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the bank's clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating Procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help exe...

Seeking candidate with hands-on experience in compiling/reviewing ACTD & CTD dossiers, regulatory documentation, and timely submissions. Must coordinate with teams, follow regional guidelines, and manage multiple projects efficiently.

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier c...

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 Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.

Ensure documentation of Forest Clearance application & Wildlife Clearance application with consultant Ensure verification of DGPS & Toposheet maps required under application Ensure compliance with forest and wildlife regulatory frameworks throughout the clearance process. Assist in preparing reports and updates for project stakeholders and regulatory bodies.

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled wit...

Role Description Operations provides support for all of Deutsche Banks businesses to enable them to deliver transactions and processes to clients. Our people work in established global financial centers such as London, New York, Frankfurt and Singapore, as well as specialist development and service centers in locations including Bucharest, Moscow, Pune, Dublin and Cary. We process payments in excess of a trillion euros across the banks platforms, support thousands of trading desks and enable millions of banking transactions, share trades and emails every day A dynamic and diverse division, our objective is to make sure that all our services are executed in a timely and professional manner, t...

Roles & Responsibilities Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation Assist the Team Lead/Manager in the development of schedules to ensure timely delivery Manage timelines and communicate with team members to maintain awareness of expectations, m...

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