163 Dossier Jobs - Page 5

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

1. Regulatory Submissions: Preparation and compilation of dossiers in CTD/eCTD formats for domestic and international markets (ROW countries). Submission of registration applications for new products and variations (post-approval changes). 2. Documentation: Review and verification of technical documents such as Product Information Leaflets, Labels, SPC, COAs, Stability Data, Product Development Reports, etc. Coordination with R&D, QA, QC, and production teams for required documents and data. 3. Regulatory Compliance: Ensure products and documentation comply with applicable regulations and guidelines (ICH, WHO, FDA, EMA, CDSCO, etc.). Monitor regulatory changes and ensure timely updates to in...

Position: Regulatory Affairs Executive Location: Andheri (E) Role & responsibilities Ensure that the company's products comply with the regulations of the regions where they are distributed. Keep up to date with national and international legislation, guidelines and customer practices. Prepare dossiers, documents and samples as per requirement of markets for participation in tenders. Collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats. Monitor and set timelines for registrations variations and renewal approvals and submissions. Write clear, accessible product labels and patient information leaflets. Advise c...

Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to

Job Summary: We are looking for a Business Development professional to handle pharma formulation exports to the Latin America (LATAM) region. The role involves client acquisition, product registration , and growing sales for injectable and oral dosage products. Key Responsibilities: Handle B2B sales of formulations in LATAM markets Build and maintain strong client relationships Coordinate dossier registration and regulatory submissions Generate and achieve export sales targets Attend pharma exhibitions, trade shows, and client meetings Candidate Profile: Must have experience in pharma exports formulations Exposure to LATAM markets (e.g., Brazil, Mexico, Colombia, etc.) Should know or be comf...

Job Summary: We are looking for a Business Development professional to handle pharma formulation exports to the Latin America (LATAM) region. The role involves client acquisition, product registration , and growing sales for injectable and oral dosage products. Key Responsibilities: Handle B2B sales of formulations in LATAM markets Build and maintain strong client relationships Coordinate dossier registration and regulatory submissions Generate and achieve export sales targets Attend pharma exhibitions, trade shows, and client meetings Candidate Profile: Must have experience in pharma exports formulations Exposure to LATAM markets (e.g., Brazil, Mexico, Colombia, etc.) Should know or be comf...

Location:Chembur Manage regulatory processes for pharma formulations in CIS, LATAM & Africa. Compile/review ACTD & CTD dossiers, handle MOH queries, ensure compliance, coordinate globally, maintain records, and lead a regulatory team to meet goals.

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory. Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.

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 Stay current with evolving regulations related to Sulphur import/export in different countries, including customs regulations, trade agreements, and safety standards. Documentation: Prepare and manage import/export documentation, including permits, licenses, certificates of origin, invoices, and shipping documents. Compliance: Ensure compliance with all relevant import/export laws, regulations, and trade agreements for Sulphur. Supplier/Customer Relationship Management: Work with suppliers and customers to ensure compliance with import/export regulations. Licensing and Permitting: Obtain and maintain necessary import/export licenses and permits for Sulphur shipments. ...

Education : Bachelor/ masters degree in a related field (Pharmacy or Chemistry); Diploma in Regulatory Affairs. Location : Thane Experience: 5-10 years of proven experience in regulatory affairs, specifically with US, EU, UK, and Emerging markets & experience in injectables In-depth knowledge of ICH guidelines, ASEAN CTD requirements, and eCTD publishing. Hands-on experience with regulatory document preparation and review. Strong understanding of QbD principles and ability to analyze trend data. Domain / Functional Key Skills: Keeping up-to-date with changes in regulations and ensuring compliance. Proficiency in preparing, reviewing, and submitting regulatory documents. Ensuring all necessar...

Knowledge and Skills Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System.

Alembic Pharma is hiring: The regulatory affairs professional will be responsible for preparation and submission of ANDA, ensuring compliance with current regulatory requirements. Job profile: To execute regulatory plans aligned with business strategy for complex drug products Review of protocols, reports, batch documents, development data received from stakeholders and ensure compliance of documents. To perform gap analysis on regulatory documentation and propose solution and ensure required compliance. Manage documents, prepare and process compilation in eCTD Preparation of ANDA considering US FDA requirements. Preparation of amendments and supplements. Preparation and review of labeling a...

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.

Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solv...

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Markets, LATAM, ROW International @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

Hands on Experience on Regulatory Affairs of various ROW markets. Lead the team for day to day RA activity. Required Candidate profile Experience of working on Liposomes/Pegylated Liposomes/Microspheres/Resomer baseddepot/Dual chamber based components / Particle size based delayed drug delivery injectables/Lyophilised dosage forms.a

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 work...

* 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

Assists in the maintenance of registrations and licenses of the products in RA systems and database such as SharePoint and other team folders as necessary. Performs labelling reviews and assisting in project creation in the Artwork Management system (WebCenter) as needed. Ensures timely submission of in renewal, site registrations and minor product submissions to relevant Health Authorities in APAC countries. Ensures effective communication across RA (top-down and botom-up) Ensures timely Veeva Vault update related to LCM activities such as MA renewal, site registration, and other minor product submissions as needed. Supports in the request of samples collection via K2 system. Generates regi...

Role & responsibilities - Preparing Dossiers for registration of products in various ROW markets - Knowledge of CTD format is mandatory Preferred profile Qualification: B. Pharm and M. Pharm Experience: 2 years Salary: 20,000 to 40,000 per month Health insurance Accidental insurance Annual bonus

Prepare and submit regulatory documents for product approvals, renewals, variations, and notifications. Maintain up-to-date knowledge of regulatory guidelines. Dossier preparation. Support product registration processes. Required Candidate profile 1–3 years of experience in regulatory affairs. Qualification : BSC / MSC / B Pharm Office Location : Mulund

Experience in a chemical laboratory doing analysis or R&D or doing chemical regulatory work. Have ability to do lot of data search on the internet and refer books & journals Have the interest to study documents thoroughly to analyse and understand.

The candidate must have experience in servicing heavy capital equipment like, including Dump Truck, Doser, tractors, road machinery, and similar equipment. MALE ONLY. ITI OR NCVT OR DIPLOMA ONLY. Required Candidate profile Candidates from the construction and construction equipment manufacturing industries will be considered. Products include crawler dozers, excavators, road machinery, and similar equipment Perks and benefits Highest salary, Bonus, Yearly Holiday Tour, Stocks

Regulatory Strategy & Planning Submissions & Approvals Team Leadership & Governance Global Compliance & Maintenance Cross-Functional Collaboration External Stakeholder Management