162 Dossier Jobs - Page 3

We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting. Strong experience in US FDA regulations and ICH guidelines. Experience in handling pre- and post-approval submissions is required Interested candidates can share their resumes on sheetal.na@peoplefy.com

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 timel...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other domestic markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 4 years of exp in Formulation OSD 2. Willing to work in Chennai 3.Strong expertise in EU, EMA, MHRA & other international regulatory framework 4. Exposure in domestic regulatory market

Dear All, We are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! Role & responsibilities Preparation of CTD dossiers for Regulated manket [EU/UK/TGA]. 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.Pharm / M. Pharm Desired Skills Knowledge of CTD dossier preparation (EU/UK/TGA) Experience in variation filing & regulatory submissions Familiarity with ICH guidelines & compliance requirements Strong coordination & documentation skills Ability to manage timelines and regulatory queries Intereste...

ROW Market Expansion, CTD/eCTD Dossiers, Registrations, Renewals, Variations, CDSCO Compliance & Audits: Regulatory Audits, Inspections, Artwork Compliance, Promotional Materials, Risk Mitagation Mail ID- mrinmay.d@ligasure.com

JD's : Regulatory Strategy: ROW Market Expansion,CTD/eCTD Dossiers,Registrations,Renewals,Variations,CDSCO Compliance & Audits: Regulatory Audits,Inspections,Artwork Compliance,Promotional Materials,Risk Mitigation Mail-mrinmay.d@ligasure.com Annual bonus

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory s...

Position Title: Manager Formulation & Development – Tech Transfer Department: Formulation & Development Location: Vadodara Reports To: Job Overview: The Manager – Formulation & Development will oversee the successful transition of products from development (R&D or other manufacturing sites) to commercial manufacturing. This role requires in-depth expertise in technology transfer, quality control, scale-up processes, and regulatory compliance, ensuring seamless manufacturing operations and product quality. Key Responsibilities: Review of Technology Transfer Dossier (TTD): Conduct detailed reviews of TTDs to ensure accuracy, completeness, and alignment with manufacturing capabilities. Assess p...

Compilation and submission of eCTD dossier for new product (Finished) application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

Position Title: Regulatory Affairs & QA Manager Department: Quality & Regulatory Affairs Location: Bangalore Role Overview The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times. Key Responsibilities Regulatory Affairs: Develop and implement regulatory strategies for product registration, approvals, and cert...

Role & responsibilities 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LAT...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, co...

About The Role As a Senior IT Business Analyst, you work closely with software engineers on building and enhancing IT solutions which move functionalities to the new technical framework This includes specifications, architecture decisions and testing It requires collaboration with an international user community as well as a wide range of other IT colleagues across the globe, Key Responsibilities Drive building new business application functions Collect and translate business and technical requirements to developers including testing support Contribute to architecture decisions in new technical landscape and analyze dependencies on other teams Build up and share knowledge about applications ...

Role & responsibilities 1. To ensure that all required information is included in the regulatory filing. 2. To collect the documents require for dossier preparation. 3.To evaluate the country wise requirements for dossier preparation as per checklist. And compile a draft dossier as per requirements and in the format provided by the authority of the country. 4.To co-ordinate with Artwork, Purchase, QC, QA, R&D, Packaging, Licensing Department for necessary documents/data. Prepare documents for courier purpose and send the courier. 5. Keep a track of the courier to check delivery on time. Providing comments on the product, preparing and submitting a regulatory application, and working with oth...

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 acco...

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...

Job Title:Sr. International Regulatory Affairs Executive/Officer Companies: Pharma Location: Ahmedabad Bodakdev Exp: 4-6 Yrs email: jobs@winstonhrservices.com Whatsapp: 7383005000 Openings: 02 Required Candidate profile Preparing & review Dossiers for registration of products in various ROW markets Legalization of FDCA documents for respective country registration Preparing, managing FSC & COPP applications for FDCA

Role & responsibilities Responsible for overseeing all aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leadi...

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 ...

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eC...

Job description for Asst. Manager/Sr. Executive - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA. 2. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2; ANDA submissions including FDA meeting requests and packages. 3. Critically reviews and approves documentation from clinical development, non-clinical development, iPSP, Research and Development (R&D), Quality, Technical Operations, Lab...

Job description for Executive / Officer - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Compilation of various applications like CC / CGT / iPSP / PIND packages. 2. The planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2/ANDA/PAS submissions including FDA meeting requests and technical DS, DP and Clinical packages. 3. Compilation and review of Labeling and SPLs for NDA/ANDA/PAS applications. 4. Review and compilation of DMF sections for NDA/ANDA/PAS filing. 5. Ensures that project timelines are develop...

Compilation and submission of eCTD dossier for new product application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Pr...

Role & responsibilities Candidates having experience working for Russia, CIS, APAC, SSA (Sun Saharan African) and Brazil /LATAM market