37 Dossier Compilation Jobs

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna. Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement. To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement. Responsible for prepare and review Drug Master File as per respective reulatory agency guidline. Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies. To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline. Responsible for prepare Drug Master File (DMF) Deficiency response to respective regulatory agency. Responsible for prepare Drug Master File (DMF) Amendment report to respective regulatory agency. Responsible for prepare Drug Master File (DMF) Annual update report to respective regulatory agency. Assessment and notification of change to regulatory agency and customer as per regulatory requirement. Aim to serve as an internal API regulatory expert, ensuring regulatory compliance within the cross-functional teams. Responsible for scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements including continuous improvement programs.

1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timely entries of submissions / dispatches Qualifications :- A bachelors degree in B. Pharma Experienced with 1 year Should apply. Excellent communication skills Should be aware about Microsoft office [word / Excel/ PPT] - Good inData management Contact No- 8810226562

Role & responsibilities Regulatory Strategy Development : Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions. Identify regulatory pathways for new product launches and lifecycle management of existing products. Regulatory Submissions and Approvals : Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for injectables across multiple jurisdictions (e.g., Africa, CIS, LATAM). Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines. Compliance Management : Ensure that all pharmaceutical products (particularly injectables) comply with regulatory requirements in target markets across ROW. Review product labeling, packaging, and advertising materials to ensure compliance with local regulatory guidelines. Manage post-market surveillance requirements, including reporting adverse events (AEs), product recalls, or any regulatory non-compliance in the region. Cross-functional Collaboration : Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle. Provide regulatory input and support during the product development phase, particularly for injectables, which often require more complex regulatory scrutiny. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements. Regulatory Intelligence : Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice), GxP, and other relevant policies across various countries in ROW. Act as the internal subject matter expert on regulatory issues related to injectables in ROW markets. Monitor competitor activities and regulatory trends in the ROW regions, particularly for injectables. Regulatory Affairs Leadership : Lead and manage a team of regulatory professionals across the ROW regions, guiding their work in regulatory submissions and compliance activities. Provide mentoring and training to team members to enhance their regulatory knowledge and skills, particularly in the injectables segment. Risk Management & Problem Solving : Identify and mitigate regulatory risks related to the approval process for injectables in target regions. Address regulatory challenges or delays and take proactive steps to resolve issues, including negotiating with health authorities or addressing deficiencies in submissions. Regulatory Advocacy and Relationship Management : Build and maintain strong relationships with key regulatory authorities in various ROW regions, including ministries of health, regulatory bodies, and industry associations. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations and injectables. Documentation & Reporting : Maintain accurate and comprehensive regulatory files and documentation for products, especially injectables, in compliance with regional regulations. Provide regular updates to senior management on regulatory milestones, challenges, and market access status. Preferred candidate profile Must have experience into injectables dosage forms.

WALK IN DRIVE R&D MUMBAI Interested candidates need to register through the QR code or link given below (works best on Google Chrome) https://macleods.in/HR/Ad.aspx?VAL=RjFndFFJSVZWY2lSQ2ZxQXBzdzczUT09 Department : Regulatory Affair Experience : 6 - 11 Years Designation : Sr. Executive/ Executive (US, Europe, South Africa, Africa, AU, NZ & Canada) Qualification : M.Pharma Location : Mumbai Job Descripition 6 -11 years of experience in pharmaceutical regulatory affairs, including leadership roles and expertise in global regulatory requirements and guidelines including FDA, EMA, and ICH regulations. Thanks & Regards HR Team

Responsibilities: * Exp on procedure of application of new Drug * Manage COPPs, GMP, GLP compliance & SUGAM portal maintenance * Oversee license renewals, dossier reviews & NIB submissions * Trademark License & Coordinate with Drug Control Authority

- Handling vendor approval requests – filling forms, Questionnaires, sharing FAQ, documents etc. - Handling regulatory requests / queries from customers. - Maintenance of regulatory documentation in electronic format and saving key communication. Required Candidate profile - 2+ years of experience in Pharma Regulatory Affairs. - B.Pharm / M.Pharm - Good Communication skills, Time Management and IT skills

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master File, BMR, APR etc. Should be able to communicate with relevant functions for procurement of required regulatory documents Should be able to communicate with relevant business partner at country

The main purpose of the role of Team Member CDT Regulatory Affairs - AP I at CIPLA R & D is to compile dossiers in accordance with regulatory strategy, manage deficiencies, evaluate products, and submit tenders to ensure adherence to regulatory requirements for various regulated/international markets within agreed timelines. As a Team Member CDT Regulatory Affairs - AP I, your responsibilities will include reviewing documents, compiling and submitting quality dossiers in line with regulatory guidelines for various regulated/international markets to minimize deficiencies from health authorities. You will also be required to evaluate and compile quality deficiency responses for all regions to meet targeted timelines set by health authorities and customers. In this role, you will need to assess and submit product evaluations and tender documents to regional teams for DRF conversion and product commercialization. Additionally, you will be responsible for staying updated on new regulatory guidelines through ongoing training and interactions with regional teams to minimize deficiencies effectively. To be considered for this position, you should hold a graduate or post-graduate degree in Pharmacy and possess at least 5 years of relevant experience in the field of Regulatory Affairs or Quality Assurance. This position is based in Vikhroli, Mumbai.,

Responsibilities: * Oversee regulatory affairs processes * Manage dossier submissions & preparations * Ensure compliance with the Latam market requirements * Lead row market strategies * Client query resolution. * Artwork review.

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile Qualification: B. Pharm and M. Pharm Experience: Minimum 5 years in ROW market for Formulation Dossier preparation and submission Perks and benefits Salary: 40,000 to 70,000 per month Mediclaim Bonus

Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software and resources write clear, accessible product labels and patient information leaflets plan and develop product trials and interpret trial data advise scientists and manufacturers on regulatory requirements provide strategic advice to senior management throughout the development of a new product project manage teams of colleagues involved with the development of new products oversee product trials and interpret trail data undertake and manage regulatory inspections review company practices and provide advice on changes to systems liaise with, and make presentations to, regulatory authorities negotiate with regulatory authorities for marketing authorisation take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities Preferred candidate profile

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.

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.

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master File, BMR, APR etc. Should be able to communicate with relevant functions for procurement of required regulatory documents Should be able to communicate with relevant business partner at country

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication

Role & responsibilities 1) Compilation , review of dossier for US , EU , AU, Canada & IL market (ORALS/NON ORALS) 2) Review of query response prepared and compiled by regulatory associates 3) Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format. Ensure compliance with USFDA regulations through dossier compilation and submission. Manage RA activities from pre-clinical to post-marketing stages, covering both domestic and international markets. Develop expertise in drug regulatory affairs, focusing on row market requirements. Collaborate with cross-functional teams to ensure timely completion of projects.

Role & responsibilities 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. Preferred candidate profile Regulatory Affairs, ACTD, CTD, Dossier Compilation, Pharma Regulatory, RA Executive

1.To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; 7.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. 8.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 9. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 10. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. .

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

Role & responsibilities: : Experience in Canada Market Dossier compilation (Injectable & OSD dosage forms) & knowledge of regulatory procedures and guidelines (ICH). Planning, execution and assessment of product life cycle management activities and strategies (LCM & Variation) Review technical documents like Protocols, API & Drug product technical packages, Change Controls etc and prepare technical documents to support regulatory submissions Knowledge in query response to agencys questions within assigned timelines ** Canteen & Transportation Facilities are Provided

Preparation/compilation of registration,re-registration Dossier and Application as per country guidelines,Coordination,Reviewed Artwork pertaining to New Registration &renewal, Product Sample-Documentation& Supporting. Share Cv on jobs@asmohlab.com

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates working in formulations may skip this job post.

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 compilation for ACTD & CTD is mandatory. Coordination with the external stakeholders for the preparation of the regulatory documents. To be responsible for the Life cycle management of assigned products. Should have experience for Life cycle management and license Maintenance. Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Desired Candidate Profile Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Perks and Benefits Best in industry. Immediate Joiners preferred

* Collaborate with cross-functional teams on regulatory strategy . Stay current with evolving regulations related to Sulphur import/export in different countries, including customs regulations, trade agreements, and safety standards Annual bonus Provident fund Accidental insurance