113 Dossier Jobs

The role is to assist in providing the regulatory administration activities of regional regulatory function. This position is responsible for organizing, revising and maintaining all regulatory documents within the regulatory department. The individual will assist in the registration of products by preparing and submitting documentation needed for registration in India. The individual will assist the team in any other responsibility as desired for regulatory work. Education: Postgraduate in Master of Business Administration (Pharmaceutical Management) Graduate in Pharmacy Experience: 4-5 years experience in FMCG/Pharma Industry in the field of pharmaceutical, general category products

We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting. Strong experience in US FDA regulations and ICH guidelines. Experience in handling pre- and post-approval submissions is required Interested candidates can share their resumes on sheetal.na@peoplefy.com

1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timely entries of submissions / dispatches Qualifications :- A bachelors degree in B. Pharma Experienced with 1 year Should apply. Excellent communication skills Should be aware about Microsoft office [word / Excel/ PPT] - Good inData management Contact No- 8810226562

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

Dear All, We are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! Role & responsibilities Preparation of CTD dossiers for Regulated manket [EU/UK/TGA]. Co-ordination with Plant, R&D & ADL to collect inputs required for Regulatory submission. Variation filling. Timely achievement of monthly plan. Interpretation and timely query response. Education - B.Pharm / M. Pharm Desired Skills Knowledge of CTD dossier preparation (EU/UK/TGA) Experience in variation filing & regulatory submissions Familiarity with ICH guidelines & compliance requirements Strong coordination & documentation skills Ability to manage timelines and regulatory queries Interested candidates can apply or mail your resume on vaibhavi.b@titanpharma.com or -contact 022 - 6785 7000 (Ext 725). If you have good references you can share on above details. Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd

ROW Market Expansion, CTD/eCTD Dossiers, Registrations, Renewals, Variations, CDSCO Compliance & Audits: Regulatory Audits, Inspections, Artwork Compliance, Promotional Materials, Risk Mitagation Mail ID- mrinmay.d@ligasure.com

JD's : Regulatory Strategy: ROW Market Expansion,CTD/eCTD Dossiers,Registrations,Renewals,Variations,CDSCO Compliance & Audits: Regulatory Audits,Inspections,Artwork Compliance,Promotional Materials,Risk Mitigation Mail-mrinmay.d@ligasure.com Annual bonus

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.

Position Title: Manager Formulation & Development – Tech Transfer Department: Formulation & Development Location: Vadodara Reports To: Job Overview: The Manager – Formulation & Development will oversee the successful transition of products from development (R&D or other manufacturing sites) to commercial manufacturing. This role requires in-depth expertise in technology transfer, quality control, scale-up processes, and regulatory compliance, ensuring seamless manufacturing operations and product quality. Key Responsibilities: Review of Technology Transfer Dossier (TTD): Conduct detailed reviews of TTDs to ensure accuracy, completeness, and alignment with manufacturing capabilities. Assess process flow, raw material specifications, equipment needs, and facility requirements. Evaluate scalability and identify bottlenecks or challenges in transitioning from lab scale to full-scale production. Assessment of Manufacturing Feasibility: Analyse the feasibility of transferring technologies to manufacturing, including processes, equipment, and facilities. Mitigate potential issues related to scale-up and manufacturing variability. Ensure reproducibility of the process in a commercial manufacturing environment while maintaining product quality. Collaboration with Cross-functional Teams: Partner with R&D, Regulatory Affairs, Quality Assurance, and Production teams to streamline the technology transfer process. Act as a bridge between development and manufacturing teams, addressing concerns and optimizing processes. Participate in and facilitate meetings to review progress and provide actionable feedback. Evaluation of Process Validation Plans: Review process validation strategies, protocols, and acceptance criteria. Ensure validations align with manufacturing capacity and regulatory requirements. Assess results of process qualification and validation batches to guarantee robustness. Risk Assessment and Mitigation: Conduct risk assessments to identify critical control points, potential failure modes, and quality risks. Develop and implement quality control measures in collaboration with the quality team. Propose process, equipment, or material modifications to enhance manufacturability and reduce costs or risks. Compliance and Documentation: Ensure adherence to local and international regulatory requirements (e.g., FDA, EMA, ICH). Review TTD documentation for regulatory alignment and maintain accurate records for inspections. Troubleshooting and Problem Solving: Provide technical support during initial manufacturing runs and address product or process issues. Identify gaps or inconsistencies in the process and implement corrective actions. Continuous Improvement: Recommend improvements based on TTD reviews and manufacturing performance. Identify opportunities to enhance efficiency, cost-effectiveness, and product quality. Key Skills: Technical Skills: Expertise in manufacturing processes, equipment, and scale-up principles. Knowledge of analytical techniques and quality control measures. Ability to interpret complex technical documents and implement actionable manufacturing strategies. Soft Skills: Strong communication and interpersonal skills for effective cross-functional collaboration. Problem-solving skills to address complex manufacturing challenges. Analytical thinking and attention to detail. Qualifications & Experience: Education: Master's degree in Pharmaceuticals (M. Pharm) or equivalent. Experience: 10-15 years of experience in manufacturing, product development, and technology transfer. Proven ability to lead and manage a team of approximately 10 members. Skills: Deep knowledge of GMP, process validation, and regulatory standards. Strong leadership abilities and a proactive approach to process optimization.

Compilation and submission of eCTD dossier for new product (Finished) application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

Position Title: Regulatory Affairs & QA Manager Department: Quality & Regulatory Affairs Location: Bangalore Role Overview The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times. Key Responsibilities Regulatory Affairs: Develop and implement regulatory strategies for product registration, approvals, and certifications (CE marking, US FDA, CDSCO, etc.). Prepare, compile, and submit regulatory dossiers for global markets. Act as liaison with regulatory authorities, notified bodies, and certification agencies. Monitor changes in global regulatory requirements and assess impact on company products. Support product labeling, claims, and advertising compliance with regulations. Maintain regulatory databases, technical files, and Design Dossiers. Quality Assurance: Lead and maintain the companys Quality Management System (QMS) in line with ISO 13485, ISO 14971 (Risk Management), MDR, and FDA QSR (21 CFR Part 820) . Plan, conduct, and manage internal and external audits (regulatory, customer, notified body). Ensure effective CAPA (Corrective and Preventive Action) and complaint handling processes. Oversee supplier qualification, incoming inspection, and vendor audits. Ensure proper document control, change control, and training compliance. Drive continuous improvement in quality systems, manufacturing processes, and compliance culture. Cross-functional Support: Work closely with R&D and Manufacturing for design control, risk assessment, and regulatory compliance during product development. Support clinical evaluation, PMS (Post-Market Surveillance), and vigilance reporting. Provide training and regulatory/quality guidance to internal teams. Key Requirements Education: Bachelors / Masters degree Experience: Minimum 610 years in Regulatory Affairs and Quality Assurance in the medical device industry . Strong knowledge of ISO 13485, MDR 2017/745, IVDR, US FDA 21 CFR Part 820, ISO 14971, IEC 60601, and other relevant standards . Proven experience in regulatory submissions, audits, and product registrations . Excellent understanding of QMS implementation and maintenance . Strong analytical, documentation, and project management skills. Effective communication and leadership skills to work with cross-functional teams and external regulators. Kindly fill the below mentioned details Notice Period: Current Salary: Expected Salary: Current Address: Experience in USFDA: Experience in EU MdR: Experience in CDSO: Experience in Product Registration: Availability for a Google Meet interview Preferred Date: Preferred Time: Kindly share your update resume to Mithun@futura.limited or WhatsApp: 6366138846 .

Role & responsibilities 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives.

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs LCM tasks of building dossiers and Coordination for LCM activities accordance with ICH and Global Requirements and guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example Build regulatory submission strategy, author regulatory documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory ServicesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamAgility for quick learningVeeva Vault and Regulatory Life Sciences Requirements Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

About The Role As a Senior IT Business Analyst, you work closely with software engineers on building and enhancing IT solutions which move functionalities to the new technical framework This includes specifications, architecture decisions and testing It requires collaboration with an international user community as well as a wide range of other IT colleagues across the globe, Key Responsibilities Drive building new business application functions Collect and translate business and technical requirements to developers including testing support Contribute to architecture decisions in new technical landscape and analyze dependencies on other teams Build up and share knowledge about applications and processes Communicate with international user community as well as a wide range of other IT colleagues across the globe Help to embed our culture of continuous improvement Drive implementation of new application services from specification to roll-out Monitor and maintain interfaces, implement data quality checks Monitor system processes, analyze errors and incidents and propose improvements Support operations inclusive developing and processing quality assurance checks About The Team The position is part of the newly created Cashflow Enhancement team within Subledger input preparation product area and team members based in Zurich, Bratislava and Hyderabad We are responsible for business applications built on Lakehouse architecture (Azure Data Lake) using Python to enable our customers to run their accounting processes and generate data which ultimately feed the SAP and other sub-ledgers with inputs for financial closing, About You - 8+ years of IT experience as a Business Analyst in the insurance or reinsurance industry, Knowledge of insurance products, reinsurance contracts, and related financial concepts Understanding of regulations like Solvency II/IFRS 17 or relevant standards, Proficiency in SQL and experience in data analysis tools Experience in Dbx will be an added advantage, Experience with ETL processes and data warehousing will be an added advantage Ability to analyze complex data, identify trends, and develop innovative solutions, Ability to create clear user stories, process flows, use case scenarios, and other relevant documentation, Previous experience with Python and Microsoft Azure DevOps tech stack will be added advantage Experience with project management tools, methodologies, and Agile methodologies, Ability to work under pressure, prioritize and re-prioritize around changing organizational objectives and timelines Strong interpersonal and communication skills, demonstrating a clear and articulate standard of written and verbal communication Ability to manage own workload and Self Directed, Feels comfortable to perform in an Agile environment, Swiss Re is one of the worlds leading providers of reinsurance, insurance, and other forms of insurance-based risk transfer, working to make the world more resilient We anticipate and manage a wide variety of risks, from natural catastrophes and climate change to cybercrime Combining experience with creative thinking and cutting-edge expertise, we create new opportunities and solutions for our clients This is possible thanks to the collaboration of more than 14,000 employees across the world, Our success depends on our ability to build an inclusive culture encouraging fresh perspectives and innovative thinking We embrace a workplace where everyone has equal opportunities to thrive and develop professionally regardless of their age, gender, race, ethnicity, gender identity and/or expression, sexual orientation, physical or mental ability, skillset, thought or other characteristics In our inclusive and flexible environment everyone can bring their authentic selves to work and their passion for sustainability, If you are an experienced professional returning to the workforce after a career break, we encourage you to apply for open positions that match your skills and experience, About Swiss Re Swiss Re is one of the worlds leading providers of reinsurance, insurance and other forms of insurance-based risk transfer, working to make the world more resilient We anticipate and manage a wide variety of risks, from natural catastrophes and climate change to cybercrime We cover both Property & Casualty and Life & Health Combining experience with creative thinking and cutting-edge expertise, we create new opportunities and solutions for our clients This is possible thanks to the collaboration of more than 14,000 employees across the world, Our success depends on our ability to build an inclusive culture encouraging fresh perspectives and innovative thinking We embrace a workplace where everyone has equal opportunities to thrive and develop professionally regardless of their age, gender, race, ethnicity, gender identity and/or expression, sexual orientation, physical or mental ability, skillset, thought or other characteristics In our inclusive and flexible environment everyone can bring their authentic selves to work and their passion for sustainability, If you are an experienced professional returning to the workforce after a career break, we encourage you to apply for open positions that match your skills and experience, Keywords Reference Code: 134531

Role & responsibilities 1. To ensure that all required information is included in the regulatory filing. 2. To collect the documents require for dossier preparation. 3.To evaluate the country wise requirements for dossier preparation as per checklist. And compile a draft dossier as per requirements and in the format provided by the authority of the country. 4.To co-ordinate with Artwork, Purchase, QC, QA, R&D, Packaging, Licensing Department for necessary documents/data. Prepare documents for courier purpose and send the courier. 5. Keep a track of the courier to check delivery on time. Providing comments on the product, preparing and submitting a regulatory application, and working with other team members to help with the process. Preferred candidate profile : Reputed Pharma background only

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile Qualification: B. Pharm and M. Pharm Experience: Minimum 5 years in ROW market for Formulation Dossier preparation and submission Perks and benefits Salary: 40,000 to 70,000 per month Mediclaim Bonus

Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software and resources write clear, accessible product labels and patient information leaflets plan and develop product trials and interpret trial data advise scientists and manufacturers on regulatory requirements provide strategic advice to senior management throughout the development of a new product project manage teams of colleagues involved with the development of new products oversee product trials and interpret trail data undertake and manage regulatory inspections review company practices and provide advice on changes to systems liaise with, and make presentations to, regulatory authorities negotiate with regulatory authorities for marketing authorisation take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities Preferred candidate profile

Job Title:Sr. International Regulatory Affairs Executive/Officer Companies: Pharma Location: Ahmedabad Bodakdev Exp: 4-6 Yrs email: jobs@winstonhrservices.com Whatsapp: 7383005000 Openings: 02 Required Candidate profile Preparing & review Dossiers for registration of products in various ROW markets Legalization of FDCA documents for respective country registration Preparing, managing FSC & COPP applications for FDCA

Role & responsibilities Responsible for overseeing all aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leading the preparation and submission of regulatory dossiers to health authorities for new drug applications, variations, renewals, and post-market surveillance reports. Ensuring adherence to all applicable regulatory requirements, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and labelling regulations. Building and maintaining strong relationships with regulatory agencies, proactively addressing any concerns or queries regarding product submissions. Managing and developing a team of regulatory professionals, including regulatory affairs managers, specialists, and associates, ensuring their expertise is utilized effectively. Monitoring changes in regulatory landscape, interpreting new guidelines, and communicating potential impacts to internal stakeholders. Identifying and mitigating potential regulatory risks associated with drug development and commercialization. Facilitating communication between regulatory affairs, research and development, clinical operations, marketing, and other cross-functional teams to ensure alignment on regulatory strategies . Preferred candidate profile Deep understanding of global pharmaceutical regulations, including ICH guidelines and relevant regional regulations. Extensive experience in the drug development process, from pre-clinical to post-market surveillance. Proven leadership skills in managing and motivating a regulatory affairs team. Excellent communication, negotiation, and interpersonal skills to effectively interact with regulatory agencies and internal Stakeholders. Strong analytical and problem-solving abilities to assess complex regulatory issues and develop solutions.

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

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively • Good understanding of clinical trial and product life cycle EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc EXPERIENCE: 4 to 6 years of Regulatory Writing/Reviewing experience LOCATION: Bangalore (Office-based/Hybrid) SKILLS: • Good communication skills (Written and Oral) • MS Office (Excel and Power point) PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES: • Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects) o Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD) o Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development o Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development o Conduct quality checks to ensure the accuracy and consistency of data included in documents o Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas o Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism o Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation and technical requirements like language, grammar, style, content search, summarizing, data conflicts and referencing o Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones o Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective • Broad Area-2: Review Content of Team Members o Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact check o Guide team members on content client requirements and quality aspects of content development for different deliverables development (including but not limited to Protocols, IBs, ICF, clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD), o Guide team members to develop content outlines for different target groups that are accurate, clinically relevant, reflecting the most recent medical advances and in accordance with established content development practices, in collaboration with clients and team leads • Broad area-3: Process Adherence and Compliance o Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy o Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client o Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms o Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines • Broad Area-4: Self-Development o Support in developing technical training programs for other team members relevant to the job o Responsible to complete client-specific training, if applicable o Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas o Learn the basic skills to manage teams o Participate in and contribute to various continuous improvement initiatives or company driven initiatives Interested Candidate Please Apply - India.hr@infinitysts.com

Job description for Asst. Manager/Sr. Executive - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA. 2. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2; ANDA submissions including FDA meeting requests and packages. 3. Critically reviews and approves documentation from clinical development, non-clinical development, iPSP, Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments, internal and stakeholders, vendors and consultants. 4. Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale. 5. Interprets regulations and guidance documents and provides strong regulatory leadership to project teams to ensure regulatory success. Candidate Profile: 1. Minimum of M.Pharm./M.Sc./Ph.D. with 5 to 10 years experience in the pharmaceutical industry, with at least USFDA working experience. 2. Strong analytical skills and business acumen specific to operational activities and product launches in generics. 3. Cross-functional collaboration skills with the ability to network with different functional areas and integrate cross-functional deliverables. 4. Sterile injectable and Solid Oral Dosage form registration experience candidates are required. 5. Proficiency in eCTD software, SPL, MS Office, MS Project. 6. Strong oral interpersonal and written communications skills.

Job description for Executive / Officer - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Compilation of various applications like CC / CGT / iPSP / PIND packages. 2. The planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2/ANDA/PAS submissions including FDA meeting requests and technical DS, DP and Clinical packages. 3. Compilation and review of Labeling and SPLs for NDA/ANDA/PAS applications. 4. Review and compilation of DMF sections for NDA/ANDA/PAS filing. 5. Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale. 6. Updates of status and trackers of Regulatory submission. Candidate Profile: 1. Minimum of M.Pharm./M.Sc./Ph.D. with 1 to 5 years experience in the pharmaceutical industry, with at least USFDA working experience. 2. Strong analytical skills; Operational activities and product launches in generics. 3. Cross-functional collaboration skills with the ability to network with different functional areas and integrate cross-functional deliverables. 4. Sterile injectable and Solid Oral Dosage form registration experience candidates are required. 5. Proficiency in eCTD software, SPL, MS Office & MS Project. 6. Strong oral interpersonal and written communications skills.

Compilation and submission of eCTD dossier for new product application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Preferred candidate profile Hiring for API & Formulation background candidates for Regulatory Affairs Team Good Communication Skill in English