212 Dossier Jobs

Role & responsibilities Market Experience : Australia / New Zealand / South Africa / EU / UK/ WHO Preparation, compilation, review, and submission of new product registrations, and duplicate marketing authorizations for assigned projects. Due diligence for product registration documents and compilation of requirement matrix. Compilation, review, and submission of documents and timely co-ordination with Agencies until approval from national authority. Preparation and compilation, review, and submission of responses of deficiencies received from Agency and MAH. Review and finalization of operational and technical documents and assessment protocols and reports. Handling of Document management s...

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...

- Compilation & review of AMV, PV data - Preparation of CTD and ACTD dossier modules - Complete dossier preparation as per ROW market, Latam - Handling of regulatory queries - Follow up with client's regulatory - Job allocation to the subordinates

Department - Regulatory Affairs (Formulation) Role & responsibilities - Preparation of successful pharmaceutical license application to Global Regulatory agencies. Reviewing regulatory documents such as manufacturing batch records, packaging batch records, analytical method, validation protocol and reports, stability protocol and record cards. Responsible for co-coordinating with cross-departmental teams such as Contract Lab and Contract Manufacturer for timely submission if required, collection of documents, review of documents and resolving any regulatory discrepancies. Responsible for compiling regulatory documents including Quality Module of Dossier for Global market as per regional requ...

Company Name: Exemed Pharmaceuticals Designation - IRA Officer/Sr.Officer Location - Vadodara ( Corporate Office) Role & responsibilities Prepare, review, compile and submit regulatory dossiers (CTD/ACTD/Country specific format). Communicate with cross functional team for CMC documents, review and provide feedback to team. Keep up-to-date with changing global regulations. Communicate regulatory updates to internal teams. Maintain updated regulatory files and technical documents till Product life cycle management. Respond to regulator queries received from Internal and External stake holders within timeframe. Review of artworks as per labelling requirement of various countries for regulatory ...

Prepare, review, and maintain regulatory documentation. Prepare dossiers. Assist in filing applications, registrations, renewals. Freshers & experienced can also apply.

Position Summary The Regulatory Affairs Manager is responsible for leading regulatory strategy, planning, documentation, and submissions for medical device products across global markets, including the EU (EU MDR), United States (FDA), India (CDSCO), and other applicable regions. This role ensures compliance with all regulatory requirements throughout the product lifecycle and partners closely with cross-functional teams to support product development, registration, and market expansion. Key Responsibilities Regulatory Strategy & Planning Develop and execute global regulatory strategies to support new product introductions, changes, and lifecycle management. Interpret and apply regulatory re...

Position Summary The Regulatory Affairs Manager is responsible for leading regulatory strategy, planning, documentation, and submissions for medical device products across global markets, including the EU (EU MDR), United States (FDA), India (CDSCO), and other applicable regions. This role ensures compliance with all regulatory requirements throughout the product lifecycle and partners closely with cross-functional teams to support product development, registration, and market expansion. Key Responsibilities Regulatory Strategy & Planning Develop and execute global regulatory strategies to support new product introductions, changes, and lifecycle management. Interpret and apply regulatory re...

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...

Job Title: Manager II – India Regulatory and business Conitnuity Business Unit: R&D1 Regulatory Affairs Job Grade G11A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key Responsibilities: To evalua...

Designation :-Assistant Manager/ Deputy Manager - RA Experience:- 10+ yrs Qualification:- B.Sc./ M.Sc., B.pharm/ M.Pharm Job Location: Ahmedabad (Plant Location) Market: ROW Market JD:- Arrangement of plant related documents for dossier preparation To support during GMP inspection and compliance at manufacturing sites Support to corporate RA for renewal of Manufacturing License, WHO GMP approval, Loan Licenses, TP Approval, Drug License. Timely query response related to manufacturing sites. Artwork verification and approval. Internal training to enhance the knowledge and capability for dossier preparation/ query solving. * Please note this vacancy is for our plant location. Interested candid...

1. Develop & execute regulatory strategies for OSD & Ointment product registrations across LATAM & CIS regions 2.Prepare, review, and submit dossiers in CTD/ACTD/eCTD formats 3. Ensure regulatory compliance for OSD and Ointment products Required Candidate profile 1. Masters in Pharma 2. 6–10 yrs of exp in Regulatory Affair in OSD 3. Must hav solid exp handling OSD & Ointment filings for LATAM & CIS 4. Strong understanding of stability studies, bio-equivalence

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (...

Job Summary We are seeking an experienced Regulatory Affairs Manager Brazil Market Specialist to lead and manage regulatory activities for ANVISA (Agncia Nacional de Vigilncia Sanitria) submissions and compliance. The ideal candidate should have strong knowledge of Brazilian regulatory frameworks, registration procedures, post-approval lifecycle management, and strong coordination with cross-functional teams and local partners/distributors. Key Responsibilities 1. Regulatory Strategy & Compliance Develop and execute regulatory strategies for product registrations in Brazil. Ensure full compliance with ANVISA regulations , guidelines, and national requirements. Monitor regulatory changes in B...

1. Biosimilar Regulated market submissions - US / EU market submission. Preferred US FDA .Alternatively candidates having exp in Small molecules and injectables for US. 2. Should Have dossier authoring for CMC for EU market. 3. Should have authoring of pre approval dossiers and query responses for US and EU. 4. Biosimilar Product Development Strategy for CMC and Clinical trials 5. Review of all Dossier related Quality documents including coordination with Cross functional teams ( RD, QC/QA and Manufacturing) . 6. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions 7. MOH Query response. 8. Biosimilar Product Life cycle Management. 9. RA support for Plant related ...

1. Biosimilar Regulated market submissions - US / EU injectable market submission. 2. Biosimilar Product Development Strategy for CMC and Clinical. 3. Review of all Dosisier related Quality documents including coordination with Cross functional teams ( RD, QC/QA and Manufacturing). 4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions. 5. MOH Query response. 6. Biosimilar Product Life Cycle Management. 7. RA support for Plant related QMS activities.

Job Title: RA Profile (EU Market Dossier Preparation) Department: Regulatory Affairs Qualification: Masters in Pharmacy Reporting: Manager Global Regulatory Affairs Role & responsibilities Regulatory submissions to the EU Market subsequently comply with applicable regulatory requirements. Compile and review all documents required in line with the relevant guidelines. Coordinate with relevant departments and prepare submissions. Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalise the documents, coordinate and prepare submissions Review technical reports, summary documents and change controls (chemistry, manufacturing and analy...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Global regulatory experience or knowledge is added advantage. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readi...

Title: Regulatory Officer We are seeking a detail-oriented Regulatory Officer with hands-on experience in handling export regulations for pharmaceutical products across African and Middle Eastern markets. The ideal candidate will have a science background and be well-versed in regional regulatory frameworks, dossier preparation, and registration processes. Key Responsibilities: Prepare, review, and submit registration dossiers as per country-specific guidelines. Ensure compliance with regulatory requirements for product exports to Africa and the Middle East. Liaise with local authorities, distributors, and regulatory consultants. Monitor changes in regulatory policies and update internal tea...

Job Title: Executive – Regulatory & Business Continuity Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Description: Preparation of registra...

We have urgent requirement for our new establish regulatory plant in Derabassi ,We required : Department : Drug Regulatory Affairs Designation : Sr. Executive Experience Required : 03 years to 06 years Salary : As per Company Norms Location : Dera Bassi Experience Required : Minimum 1 year Experience required in regulatory Markets. Interested Candidates can apply at hr2@theonpharma.com or hr@theonlifesciences.com or contact at 7018311459 / 9592224274

Responsibilities: * Ensure compliance with regulatory requirements * Prepare DMF submissions * Collaborate with cross-functional teams on dossier preparation * Maintain accurate records and documentation Leave encashment Gratuity Provident fund Health insurance Annual bonus

Manager – Regulatory Affairs & Advocacy Gurugram – Full time About Absolute : Absolute is a bioscience company founded with the idea of a shared future where both people & planet win together. The company’s vision is to build a thriving future for people and the planet by harnessing the power of nature, science & exponential innovation. Today, Absolute’s Bio division has evolved into a generation-defining bioscience company across Agriculture, Human Health & Sustainable Materials. Operating across 30+ countries, Absolute’s Agtech businesses encompass – Climate Solutions, Soil Health testing, Crop Insurance & Tech driven commodities trade. Absolute’s revolutionary businesses are backed by, Xe...

To ensure Registration dossier submission of products in different Africa countries (Region I) as per agreed timeline. To ensure Renewal of registered product prior to validity expiration of Africa countries (Region I). To Review Registration and Re-registration dossiers before submission in all Africa countries (Region I) To maintain country-wise registered product status for all Africa countries (Region I) To co-ordinate with other departments R&D, QA and QC for ensuring the filings & query responses. To provide technical support to team for preparation of Registration/Re-registration dossiers and query responses. To prepare documents for variation filings as and when required for all Afri...

Role & responsibilities 1. . Dossier Compilation 2. Query Responses 3. Commercial Document Review 4. Post-Approval Changes 5. Change Control Review Preferred candidate profile Markets Handled : Europe ROW ( Malaysia, Singapore, Philippines, Zimbabwe, Zambia, Mexico, UAE, Oman, Qatar, Kuwait, Ukraine, Uzbekistan, Kyrgyzstan, Azerbaijan, Botswana, Mauritius, Tanzania, Kenya and FWA)