64 Dossier Jobs

About Zydus Wellness Zydus Wellness, an FMCG leader, develops, manufactures, and markets health and wellness products, integrating healthcare, skincare, and nutrition. Founded in 1988 with Sugar Free, India’s first zero-calorie sugar replacement, it now manages seven global brands, including Complan, Glucon-D, Everyuth, and Nutralite. The company serves over 50 million families and supports more than 90,000 dairy farmers and 2,000 MSMEs. With a focus on research, quality, and innovation, Zydus Wellness operates on core pillars of manufacturing integrity and supply chain efficiency. Headquartered in Ahmedabad and Mumbai, it runs four manufacturing facilities across India and eight co-packing facilities in India, Oman, and New Zealand. Listed on the Bombay and National Stock Exchanges, Zydus Wellness is led by Chairman Dr. Sharvil Patel and CEO Tarun Arora, serving customers in over 25 countries across three continents. S. No Get to know our organization – Click on the below links 1 Company Website 2 Zydus Corporate Park Job Title: Assistant Manager - Food Regulatory Affairs Location: Ahmedabad- ZCP, Gujarat, India Department: Regulatory Affairs Functional Reporting: Manager Regulatory Affairs Administrative Reporting: Manager Regulatory Affairs Job Type: Full-time Role: Responsible for ensuring compliance with all food safety and regulatory requirements for the organization’s products. This role involves supporting the preparation, submission, and maintenance of regulatory documents and licenses, coordinating with internal and external stakeholders, and staying updated with evolving food regulations. The incumbent will play a key role in safeguarding the company’s regulatory standing and facilitating market access for new and existing products Key Responsibilities: Regulatory Compliance Management: Ensure compliance with food safety laws, regulations, and standards (e.g., FSSAI regulations, BIS standards, etc.) in India. Monitor regulatory changes and assess their impact on company operations. Liaise with internal teams (R&D, Quality Assurance, Marketing, Legal) to ensure that new products meet regulatory requirements. FSSAI & Legal Documentation: Assist in obtaining and renewing relevant licenses, registrations, and certifications from regulatory authorities such as FSSAI, LM, and other local bodies. Prepare, review, and maintain regulatory documentation and product dossiers for submission to relevant authorities. Work on product labeling, claims, and packaging to ensure compliance with the Food Safety and Standards Act. Risk Assessment and Management: Evaluate potential risks related to food safety, labeling, and regulatory compliance, and propose corrective measures. Conduct risk analysis on new and existing food products to mitigate any potential non-compliance. 4. Financial Support the cost-effective management of regulatory submissions and compliance-related activities 5. Customer Ensure timely and accurate submissions to regulatory authorities to meet business timelines. Address regulatory queries and facilitate smooth approval processes for product registrations 6. Process Prepare, review, and submit regulatory documents, product dossiers, and compliance reports. Maintain regulatory records, databases, and ensure up-to-date documentation. Monitor and interpret changes in food safety regulations and communicate impact to internal stakeholders. Coordinate with R&D, Quality, and Production teams to ensure compliance of product formulations and labeling with regulatory requirements 7. People Collaborate with cross-functional teams to align regulatory activities with business objectives Develop strong working relationships with external regulatory bodies and industry association Key Deliverables Timely submission and approval of regulatory filings for new and existing products. Maintenance of accurate regulatory documentation and compliance databases. Proactive identification and communication of regulatory changes impacting business operations. Key Requirements: Educational Qualification Master’s degree in Dairy Technology or Dairy Sciences (Preference NDRI- Karnal) Additional certification or training in regulatory affairs is a plus. Experience: 1-3 years of experience in regulatory affairs, specifically related to food(Dairy) regulatory and compliance in India. Experience in preparing and handling regulatory submissions, licenses, and compliance documentation Knowledge of food safety regulations and industry standards in India. Skills and Competencies: In-depth knowledge of FSSAI regulations, food safety laws, and compliance requirements in India. Knowledge of national and international food regulations and standards (e.g., FSSAI, Codex) Expertise in regulatory documentation, labeling compliance, and product registrations Familiarity with food safety systems and quality management practices Strong written and verbal communication skills. Attention to detail with the ability to manage multiple projects simultaneously. Strong analytical and problem-solving skills. Ability to work cross-functionally with internal teams and regulatory authorities. Personal Attributes: Proactive and self-driven with the ability to work independently. Strong organizational skills with the ability to prioritize tasks effectively. Ability to maintain confidentiality and handle sensitive information with discretion. Behavioral Competencies Zydus Neev Behavioural Competency Framework Clear and concise communication skills to convey complex regulatory requirements Strong interpersonal skills to work with cross-functional teams and external authorities Meticulous approach to maintaining regulatory documentation and ensuring compliance

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

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization. JOB RESPONSIBILITIES : ;;;;;;;;;;;;; Accountabilities;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work US Drug Dossier Authoring, Reviewing and Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation and Submission Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan and complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination Interface with R and D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R and D/ADL against DMF/Dossier requirements Reporting and Maintenance Maintain regulatory files/database

Seeking for experienced & strategic Regulatory Affair leader. will oversee all regulatory submission activities, maintain compliance with evolving global health authority requirements & provide expert regulatory guidance for pharmaceutical products

Role & responsibilities * Data Entry and Updation in Regulatory Information Management System. * Dossier preparation (New/ Renewal/ Variations) for different countries. * Other RA Related Activities. Perks and benefits * 5 days working Environment * Additional Benefits.

Regulatory Affairs Executive ( for Cosmetic Industry ) Kheda, Gujarat 3–5 Years Experience CTC up to 6 LPA Strong knowledge of global cosmetic regulations (EU/USA/ASEAN/Gulf) Expertise in labeling, claims review, and documentation

Role & responsibilities 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development and commercialization. 8. Conduct training sessions on regulatory updates and internal System 9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations. 10. Support internal and external audits by providing required regulatory documents and justifications. 11. Guide and review work of junior team members or trainees. 12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates. 13. Review of all dossiers related technical documents Preferred candidate profile Experience in reviewing of Analytical documents

Role & responsibilities : Extend support on the compiling, submission and approval of Country Specific Submissions files for the responsible countries (NDA, LCM & post approval changes) Participate and extend support during initial submission planning Review & update the list of documents required for the submission (e.g., NDA, variation, tenders) Manage compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes Preferred candidate profile :

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs. Perks and benefits PF CANTEEN TRANSPORTATION

Preparation of dossiers for semi-regulated & non-regulated markets. Responding to queries raised by the Ministry of Health (MOH) & buyers regarding dossiers. Coordinating the dispatch of samples(working standards & finished products) for registration Required Candidate profile Collecting documents required for tenders & completing relevant questionnaires. Liaising with plants & internal departments to gather necessary documents and samples, Supporting the Sectional Head.

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.