201 Dossier Preparation Jobs

Job Title: Executive / Senior Executive Regulatory Affairs (API) Location: Noida or Hyderabad, India Job Type: Full-Time Role Overview: We are seeking a motivated and detail-oriented Regulatory Affairs Professional to join our API regulatory team. The candidate will be responsible for preparing and reviewing eCTD sections of regulatory submissions (ASMF/CEP) and data packages for European markets, ensuring compliance with international regulatory standards. Key Responsibilities: Coordinate with cross-functional departments to arrange required technical data for ASMF/CEP and technical package preparation . Review quality and manufacturing data for APIs for regulatory adequacy as per relevant ...

Role & responsibilities We have opportunity in Regulatory Affairs for Emerging Markets Position: Officer/Executive/Assistant Manager Regulatory Affairs Experience: 3-6 Years and 8+Years for Assistant Manager Qualification: B.Pharm/M.Pharm Location: Ahmedabad 1. Compilation of dossiers in CTD, eCTD & national formats 2. Compilation and submission of Queries Response and Variation Filing. 3. Review of documents, artworks 4. Review of change controls 5. Gap analysis for new product filing 6. Maintaining product Life cycle Candidates having experience LATAM/CIS/ Africa/Asean or any other Emerging Markets can apply

Responsibilities: * Prepare regulatory dossiers for product approvals * Collaborate with cross-functional teams on dossier updates * Ensure compliance with drug regulations according to NAFDAC standards. * Manage LOAs, COAs & BDNAF submissions

Dear All, We have arranged a Walk-In Interview for Regulatory Affairs (Formulations) - Executive / Sr. Executive where we are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! (Venue details are given at the end). Experience in Regulatory Affairs is must. Role & responsibilities Preparation of CTD dossiers for Regulated manket [EU/UK/TGA] or ROW market - Asia & Africa market. Experience in handling modules 1 to 5 or atleast 4 & 5 is mandatory. Co-ordination with Plant, R&D & ADL to collect inputs required for Regulatory submission. Variation filling. Timely achievement of monthly plan. Interpretation and timely query response. Education - B.Pha...

Role & responsibilities 1. DMF Complications 2. Query response preparations 3. life cycle management 4. Marketing/ Customer Communications 5. Quality Documents/ Submissions review 6. Change Control Management/ RIMS Management

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 preparat...

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, industry standards.Develop and maintain relationships with regulatory authorities Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards. Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

ONLY EXPERIENCE CANDIDATE CAN APPLY Job description: - We are looking for a Regulatory Affairs Executive with strong knowledge of pharmaceutical products. The candidate must have experience in domestic regulatory compliance (FSSAI/CDSCO) and export documentation , specifically for LATAM & ROW. Responsibilities include dossier preparation, label review, and coordination with departments for regulatory submissions. Key Responsibilities: 1. Handle regulatory documentation and submissions for Pharmaceutical Products (domestic & export). 2. Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Etc.) and international regulations . 3. Ensure products comply w...

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards.Develop and maintain relationships Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards. Excellent communication and interpersonal skills. Ability to work independently and as part of a team.

SR. Executive/Assistant Manager/Manager - Regulatory Affairs Roles and Responsibilities - To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. - To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSC- Procuring and legalization). - To check & approve the artworks for regulated / semi regulated countries. - To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. -Handling queries pertaining to regulatory submissions from various regulatory authorities. - Maintain re...

Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variation , ...

Role & responsibilities Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain well-organized records of submissions, ...

1. Regulatory Submissions & Approvals: Prepare, review, and submit drug regulatory dossiers (e.g., Formulations, APIs, supplements) to CDSCO, state FDA, and other authorities . Follow up on approval status, queries, and responses with regulatory bodies. Maintain trackers of pending applications, renewal dates, and approvals . 2. Documentation & Compliance: Ensure preparation of regulatory documents, SOPs, product labeling, packaging inserts, and promotional materials in compliance with regulatory norms. Maintain accurate records of regulatory correspondence, approvals, and submissions . Support internal audits and inspections with regulatory documentation. 3. Product Lifecycle Management: Mo...

Position: QC Chemist ( Only Male) Job Location: Nerul, Navi Mumbai Industry: Ayurvedic / Herbal Pharmaceuticals Qualification: B.sc/ Msc ( Botany) Mandatory Experience: 0-2 Yrs Experience ( Freshers also can apply) Designation & Salary: Commensurate with industry experience and expertise. Working Days And Time: 8:00 AM to 5 PM / 6 Days week / Sunday fixed Off. Key Responsibilities: Smooth functioning and timely analysis & approval of FG, RM,PM & intermediate which is finally approved from Q.C. COA preparation for Export purpose & other documentation whenever required.Monitoring of Control sample observation register: RM & FP Monitoring of Control sample and maintaining destruction record For...

JD: 1. Ensure that a company's products comply with the regulations of the Africa regions 2. Keep up to date with national and international legislation 3. Dossier Preparation 4. Managing activities of Regulatory Affairs

Croda is a FTSE100 organisation focused on our purpose of Smart Science to Improve Lives. With a market capitalisation of 6 billion and nearly 6,000 employees globally, we are innovating new and novel ingredients for the Life Sciences industry through our commitment to sustainability and customer centricity. As our Seed business looks to deliver its ambitious strategy of growth, we are looking for a Seed Technology R&D Leader to join our organisation to Lead the Seed Technology Research & Development function across India, focusing on innovation, product development, and technical support for seed enhancement technologies. Drive strategic research initiatives aligned with global and regional...

Need Sr. RA Executive for a Reputed Pharmaceutical Company at Ahmedabad. Jobless Candidate with positive mindset to join immediately will be preferred. Notice period allowed is maximum 30 days. Apply of WhatsApp at 9879604156

We are looking for 3-6 years experienced QA Manager and having worked in Medial Devices / Pharma manufacturing industry, particularly in handling SOP's, DMF, SMF and CDSCO Regulatory approvals , GMP audits, documentation processes. familiar ISO13485 Required Candidate profile Candidates with graduation in molecular biology, B pharmacy with thorough knowledge about DMF,SOPs preparation ,SMF, GMP audits,must know about complete documentation and Quality assurance procedures

We are seeking an experienced and detail-oriented Executive Regulatory Affairs (ROW) to join our Regulatory team. The ideal candidate will be responsible for preparing, reviewing, and submitting dossiers for semi-regulated and non-regulated markets, ensuring compliance with global regulatory requirements, and coordinating with internal departments and external stakeholders for product registration and documentation. Key Responsibilities: Prepare and compile regulatory dossiers for semi-regulated and non-regulated markets (ROW). Respond to queries and deficiencies raised by the Ministry of Health (MOH) or buyers related to dossiers and submissions. Coordinate the arrangement and dispatch of p...

Role Overview: As a Regulatory Affairs Specialist at Philips, you will be recognized as a key talent in International Regulatory filings and procedures. You will play a crucial role in the Centralization of Regulatory Operations to ensure regulatory compliance in markets where Philips products are commercialized. Your expertise will be invaluable as you contribute as a key regulatory point person. Additionally, you will be an impactful member of the Regulatory Affairs (RA) team, trusted by management to handle multiple projects independently. Your responsibilities will include assisting in the establishment of a center of excellence for RA operations to centralize regulatory functions for im...

Roles and Responsibilities (5 days working) Dossier (CTD, ACTD & Country Specific Format) review for Latam, ASEAN, CIS & African countries. Collaborate with various departments within the organization, such as Plant (QA, QC, Production, Packing & Purchase) and R&D, to gather the necessary inputs for regulatory submissions. Compilation and timely submission of Dossiers to the respective regulatory authorities in the assigned countries. Planning, monitoring, review, strategy & delegation of the below mentioned activities for Countries: New Product Registration, Re-Registration, Retention, Tender. Handling of queries from various regulatory authorities/consultants. Post Approval Changes GMP (Co...

Sakar Healthcare Ltd incorporated in 2004 has emerged as a leading pharmaceutical manufacturer based in Western India, specialized with innovative oncology solutions. With the research-driven API-integrated EU GMP approved oncology orals & injection formulation manufacturing units, Sakar is ready to cater the global markets with diverse product range and business models. Mentor regulatory team of 12, conduct training sessions on the latest regulatory updates have experience of trouble shooting with good communication skills client handling. Preparing/ checking and submitting technical files and compilation of dossiers in CTD format of Product life-cycle management in ROW & EU markets. Ensuri...

Role & responsibilities Dossier and regulatory document preparation Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations Visiting FDA office for follow ups on applications Preferred candidate profile Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions. Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats. Strong documentation management, including version control,...

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats. Responsible for final review of dossier before submission. Reviewing artwork for products as per relevant regulatory authority requirements. Coordination with F&D, QA, QC & Store for documentation In-depth knowledge of pharmaceutical documentation & regulatory guidelines. To coordinate with technical team for documents required for dossier. Country Experience Preferred: CIS, LATAM Dosage Form Experience: Soild Oral + Injectable Preferred candidate profile