78 Dossier Jobs - Page 2

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. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

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 internal systems and processes. 4. Product Lifecycle Management: Handle renewals, variations, and responses to regulatory queries/deficiencies. Maintain product registration databases and archival of regulatory submissions. 5. Liaison & Communication: Coordinate with regulatory authorities, agents, and external consultants as required. Attend audits and respond to regulatory inspections

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).

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 comfortable with Spanish/Portuguese Good understanding of regulatory & dossier requirements Strong communication, negotiation, and client handling skills

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 comfortable with Spanish/Portugues Good understanding of regulatory & dossier requirement Strong communication, negotiation, and client handling skills

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. Record Keeping: Maintain accurate records of all import/export transactions. Communication: Communicate with customs authorities, government agencies, and other stakeholders to ensure compliance. Problem Solving: Identify and resolve regulatory issues related to Sulphur import/export. Collaboration: Collaborate with other departments, such as logistics and finance, to ensure seamless import/export operations. Audits: Prepare for and respond to regulatory audits related to import/export activities. Preferred candidate profile Bachelor's degree : in a relevant field, such as international business, logistics, or law Understanding of international trade laws, customs regulations, and other relevant regulations. Experience : in regulatory affairs, import/export, or customs compliance. Ability to prepare and manage import/export documentation accurately and efficiently. Ability to communicate effectively with customs authorities, government agencies, and other stakeholders.

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 necessary documentation for product approval is in place, complete, and accurate. Email : monisha.lahiri@randstad.in

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 artworks Review of DMF Review of extractable, leachable, elemental impurities and nitrosamine assessment, in-use and stability data. Liaise with external stakeholders Archiving of communications and maintenance of status files and database Requirements: Education: Pharma Graduate OR Post Graduate Experience: 02- 08 years Desirable traits: Ability to manage complex projects and timelines in a matrix team environment. Ability to work independently and as part of a team. Should have hands on experience on MS word, PDF professional, eCTD software for ANDA preparation and submission. Interested candidate can share cv on bdcv@alembic.co.in

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 solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

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 working in formulations may skip this job post.

* 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 regional reports, process vendor payments and other country-related requests. Provides support on other country regulatory and cross functional activities as necessary. Conducts timely regulatory intelligence search in the relevant countries and update Country Regulatory Tool system as necessary. Takes part in Regional/Global or local hub initiatives that are relevant to support the region and hub. Supports the review and revision of hub processes to achieve efficiency across hub. Able to travel as per business need. Other Activities: a) Strategy Alignment -For Site Registration submissions only, ensures alignment with country on submission strategy as required. b) Dossier Readiness - Performs labelling reviews and assists in project creation in Artwork Management system. c) Application Submission - Supports country in renewal and minor product submissions to relevant Health Authorities. - Assists overall the maintenance of registrations and licenses of the products in RA systems and database. - For Site Registration submissions only, ensures timely submission/dispatch of the dossier related to submission and timely Veeva Vault updates. d) Application Approval - Supports country in renewal and minor product submissions to relevant Health Authorities. - Assists overall maintenance of registrations and licenses of the products in RA systems and database. e) Product Maintenance - Assists overall hub in the maintenance of registrations and licenses of the products in RA systems and database. f) Others - Provides support on other country regulatory and cross functional activities. - Generates reports, request samples collection, process vendor payments Who you are: Bachelors or Masters in Pharmacy OR p.HD Min 5-10 Years of experience in Indian Regulatory Market Fluent in written and spoken English Experience in CDSCO, Import and State FDA

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