78 Dossier Jobs

Role & responsibilities Candidates having experience working for Russia, CIS, APAC, SSA (Sun Saharan African) and Brazil /LATAM market

Description Regulatory Associate (EU Market) Homebased Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Minimum 1 year of experience in Global Regulatory Affairs, Hands-on experience in the preparation and review of global CMC dossiers, variation applications, and post-approval changes, Solid understanding of regulatory markets and authorization dossier applications across regions including: EU, US, LATAM, APAC, Middle East, Africa, and China, Proven ability to work effectively in a fast-paced, team-oriented environment, Strong aptitude and attitude to learn and grow within the regulatory domain, Candidates with internship experience in Regulatory Affairs (CMC) will be given preference, Assists with preparation of product development documents including gap analyses and clinical development plans, Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorization transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines, Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests, Performs quality checks on related documents, Assists with submissions of other regulatory documents and other regulatory research as needed, Assists clients, customers, or others with general information Gathers, compiles, analyzes, and reports information, Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence, Qualification Requirements Masters in Pharmacy (Preferred)or Masters in science/healthcare field, or equivalent combination of education and experience, Excellent interpersonal / communication skills, Advanced skills in Microsoft Office Applications, Good time and project management skills, preferred, Strong analytical skills and attention to detail, Ability to work both as a team member and independently and to understand and carry out detailed instructions, Ability to interact with staff from multiple departments, Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred, Fluent in speaking, writing, and reading English, 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http:// syneoshealth 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

Hiring for DRA Manager Location- Panchkula Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit Interested One share resume 9815675900

We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Minimum 5 Years in RA is must Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. 4. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Education: 5 - 8 years of experience in regulatory affairs, focusing on Asian markets. Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations : a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc

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

Novo Medi Sciences seeks a Regulatory Affairs Manager with 10+ yrs exp. in ACTD/CTD dossiers for semi/non-regulated markets. Location: Dadar East, Mumbai. B Pharm/M Pharm. Must handle queries, submissions, product lifecycle, and lead a team

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

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of dossier preparation guidelines for USFDA submissions. Excellent communication skills for effective collaboration with internal stakeholders.

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ 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.

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

Dear All, We are looking for a Regulatory Affairs Executive with 2-4 years of experience in pharmaceutical formulations, specifically for the ROW (Rest of World) market . Hands-on experience in the preparation and submission of regulatory dossiers in CTD and ACTD formats for Rest of the World (ROW) markets. Proficient in drafting and submitting responses to regulatory queries within stipulated timelines. Experienced in managing post-approval activities, including renewals and variations. Skilled in handling Drug Master File (DMF) notifications. Adept at reviewing and ensuring the accuracy and compliance of quality documents such as product specifications, stability data, Product Development Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Cards (MFC), and process validation protocols. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable

Role & responsibilities Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings. Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatory SOPs and documentation standards.

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.