88 Dossier Preparation Jobs - Page 2

ISO 9001 14001 45001;TPI Internal External Audits;BPVC-ASME;IBR CBB;ASTM DIN BS ANSI EN;API AWS; SOPs;FATs/SATs;Quality Dossier;TQM;Documentation;QAP;Overall QMS

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 country sales managers on regulatory requirements. Provide strategic advice to senior management throughout the development of a new product. Manage teams of colleagues involved with the development of new products. Undertake and manage regulatory internal audits .. Review company practices and provide advice on changes to systems. Liaise with, and make presentations to, regulatory authorities. Follow up with marketing team for marketing authorization, registration data and status. Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Experience in Dossier. Preferred candidate profile Qualification required: Graduate in Pharmacy/ Science Post graduate in Pharmacy/ Science Experience required: 04 to 06 years in preparing dossiers for ROW market. Should be experienced in preparing country specific dossiers. Well versed with country specific guidelines. Fluent in communication. Candidate should be living around Andheri or should be comfortable travelling to Andheri (E).

To prepare the Registration and Renewal dossiers in CTD, ACTD & Country Specific format To prepare the dossiers for allotted countries Timely answering the queries EXP in ROW market B. Pharm, M.Pharm,Science graduate/PG Required Candidate profile Exp as Head of department for ROW-Regulatory affairs Exp in Team handling kindly send resume to hr1@flamingopharma.com,sunil@flamingopharmacom

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

Role & responsibilities Contractual Role for 6 Months. Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format. Internal communication & follow-ups with various departments for various documents. To arrange and send samples for registration purpose to various countries. Review at all quality data received from various departments before using in dossiers and technical packages. Preparation and submission of Query response raised by the Health Authority. To undertake any other assignment given by superior of the department / management from time to time. To support in documentation in national and international tenders. Management of Product Database. Archival of dossier. For COPP Application- Support with documents. Preferred candidate profile Must be from Formulation background interested applicant can send CV on shital@mjbiopharm.com , janhavi.shedekar@mjbiopharm.com or contact on 9619744167. Perks and benefits

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

We are looking for a highly motivated and experienced Customer Relationship Executive to join our team in Kanpur. The ideal candidate will have 2-5 years of experience in sales, customer relationship management, or a related field. Roles and Responsibility Achieve assigned collection targets for SLCV&PV (in the 0-3 range) through effective collection strategies. Ensure timely recovery of dues and maintain strong customer relationships by monitoring accounts and ensuring compliance with legal and company policies. Develop and implement customer management plans to meet daily visit and customer target requirements. Regularly contact existing clients to maintain company presence and identify new business opportunities. Adhere to laid down processes and accept challenges in a fast-paced environment. Ensure all collection documents are submitted correctly and on-time. Job Minimum 2 years of experience in sales, customer relationship management, or a related field. Strong knowledge of banking, financial services, and broking industry practices. Excellent communication and interpersonal skills are required to build strong client relationships. Ability to work under challenging environments and meet targets. Strong analytical and problem-solving skills are needed to resolve customer issues. Proficiency in document management and submission procedures is essential.

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU, UK and AUS-NZ. Review of documents related to compilation of dossiers and query responses. Up to date knowledge of regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge, review skills and understanding of regulatory submissions Strong knowledge of CTD /eCTD requirements for modules 2 and 3 is mandatory. Hands on experience with compilation of module 1 and portal submissions would be preferable. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude. Good communication (written and oral) and inter-personal skills.

Ensuring Products and facility comply with relevant regulations and Law Prepare documents Liaison with regulatory agencies External Audit Product registration dossiers, clinical trial documentation COPP product wise approval Required Candidate profile Strong Effective communication skills including writing and presentation skills Qualification M Pharm , MSc only preferred Location Kolkata, Pharmaceutical Factory

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must have exposure to in-licensed dossier filing and out licensing

Role & responsibilities - Dossier preparation, review and submission in ACTD/CTD/ Country specific formate and also in ROW. - Review of technical documents - Responding to dossier - related queries. - License related activity. - Strong coordination with functional related department. Preferred candidate profile Dossier Preparation, Submission, Technical Review

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

1. Compilation of Post Approval requirements i.e. Annual Reports, CBE-0, CBE-30, PAS, 15-Day Alert Report, PADER etc., ensuring that quality standards are met and submissions meet strict deadlines. Provident fund Office cab/shuttle Health insurance Annual bonus

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.

Role & responsibilities Review and submission of ANDA 505 (J) application for US market. CMC writing, Query management, Labeling, RIMS, Drug Listing, Pre-and Post-Approval Changes (Life cycle management) and Publishing as per USFDA/EU. Proficient in cross functional team communication with internal and external stakeholders. Functional experience in end to end project management and handling team Preferred candidate profile Candidate must have experience in Regulatory filling and product life cycle management for in EU & US markets Perks and benefits 20lpa to 30 lpa

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.

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

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.

Key Responsibilities: Lead and manage regulatory activities and documentation (individually and through a team). Ensure compliance with South Africa/country-specific guidelines. Review and peer-review regulatory submissions (electronic & non-electronic). Track and oversee project timelines and regulatory deliverables. Liaise with internal/external stakeholders to ensure timely documentation. Prepare/review APQR summary reports and implementation notifications. Stay updated on changing regulatory legislation. Guide and train internal teams on regulatory requirements. Ideal Candidate Profile: 6-9 years of experience in Regulatory Affairs. Strong knowledge of South African and/or international regulatory guidelines. Background in Pharmacy, Life Sciences, or related field. Excellent documentation, analytical, and communication skills. Experience in handling submissions and quality checks under tight deadlines.

2-7 years of experience in Europe CTD dossier preparation Module-1,2,3,4 & 5 Compiling & submitting technical dossiers for export markets Receiving the site registration requirements Query Response Management Preparation of variation data package Perks and benefits Weekly off on all SATURDAYS & SUNDAYS

Role & responsibilities - Dossier preparation, review and submission in ACTD/CTD/ Country specific formate and also in ROW. - Review of technical documents - Responding to dossier - related queries. - License related activity. - Strong coordination with functional related department. Preferred candidate profile Dossier Preparation, Submission, Technical Review